Personal authentication apparatus system and method

ABSTRACT

A target authentication device includes an electrode to detect an electrical signal associated with a user of the device. The electrical signal represents an authentication code for the device. An authentication receiver module is coupled to the electrode. The module receives the electrical signal from the electrode and determines whether the electrical signal matches a predetermined criterion to authenticate the identity of the user based on the electrical signal. An authentication module is also disclosed. The authentication module includes one electrode to couple an electrical signal associated with a user to a user of a target authentication device, the electrical signal represents an authentication code for the device. An authentication transmission module is coupled to the electrode. The authentication transmission module transmits the electrical signal from the electrode. A method of authenticating the identity of a user of a target authentication device also is disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation-in-part of application Ser. No.13/336,956, filed Dec. 23, 2011, which is a Divisional Application ofSer. No. 12/673,326, filed Feb. 12, 2010, which application claimsbenefit of U.S. 371 National Phase of PCT/US09/68128, filed Dec. 15,2009, which application claims the benefit of Provisional Application61/122,723, filed Dec. 15, 2008, which application claims the benefit ofProvisional Application 61/160,289, filed Mar. 13, 2009, whichapplication claims the benefit of Provisional Application 61/240,571,filed Sep. 8, 2009, which application claims the benefit of ProvisionalApplication 61/251,088, filed Oct. 13, 2009, the disclosures of whichapplications are herein incorporated by reference.

This application is a Continuation-in-part of ApplicationPCT/US2012/047076 filed Jul. 17, 2012, which application claims thebenefit of Provisional Application 61/510,434 filed Jul. 21, 2011, thedisclosures of which applications are herein incorporated by reference.

INTRODUCTION

The present disclosure is related generally to authentication and/orpassing value tokens, the process of confirming the identity of a personby verifying the validity of at least one form of identification by atarget authentication device. More particularly, the present disclosureis related to employing personal authentication techniques toauthenticate users of the target authentication device.

Conventional modes of authentication include the use of passwordsgenerally composed of character strings composed of letters (a, b, c, .. . ), numbers (1, 2, 3, . . . ), and/or symbols (!, @, #, . . . )arranged in various combinations.

A minimum level of security for accessing a target authentication devicesuch as a mobile phone is achieved by requiring the owner/user of themobile phone to enter a unique four-digit character string referred togenerally as a Personal Identification Code (PIN), and a passcode in thecase of the iPhone brand of mobile phones. The amount of time a mobilephone allows access before requiring re-entry of the PIN is configurabledepending on the desired level of security of the owner. Entering aPIN/passcode, however, is a frequent burden for the owner. The owner maybe required to enter a PIN/passcode several times per hour throughoutthe day, every day. In addition to being burdensome for the user, suchminimum levels of security are easily hacked by someone skilled inexploiting weaknesses of computer systems.

More generally, however, ways in which someone may be authenticated fallinto three categories, based on what are known as the factors ofauthentication: something the user knows, something the user has, andsomething the user is. Each authentication factor covers a range ofelements used to authenticate or verify a person's identity prior tobeing granted access, approving a transaction request, signing adocument or other work product, granting authority to others, andestablishing a chain of authority. For a positive authentication,elements from at least two, and preferably all three, factors should beverified. The three factors (classes) and some of elements of eachfactor are: the ownership factors: Something the user has (e.g., wristband, ID card, security token, software token, phone, or cell phone) theknowledge factors: Something the user knows (e.g., a password, passphrase, or personal identification number (PIN), challenge response (theuser must answer a question), pattern) the inherence factors: Somethingthe user is or does (e.g., fingerprint, retinal pattern, DNA sequence(there are assorted definitions of what is sufficient), signature, face,voice, unique bio-electric signals, or other biometric identifier).

Two-factor authentication is when elements representing two factors arerequired for authentication, the term two-factor authentication isapplied—e.g., a bankcard (something the user has) and a PIN (somethingthe user knows). Business networks may require users to provide apassword (knowledge factor) and a pseudorandom number from a securitytoken (ownership factor). Access to a very-high-security system mightrequire a mantrap screening of height, weight, facial, and fingerprintchecks (several inherence factor elements) plus a PIN and a day code(knowledge factor elements), but this is still a two-factorauthentication.

Conventional modes of authentication have become increasingly burdensomeand inadequate means for security. Accordingly, new authenticationapproaches that are robust and less burdensome are needed.

SUMMARY

In one aspect, a target authentication device is provided. The targetauthentication device comprises at least one electrode configured todetect an electrical signal associated with a user of the targetauthentication device. The electrical signal represents anauthentication code for the target authentication device. Anauthentication receiver module is coupled to the at least one electrode.The authentication receiver module is configured to receive theelectrical signal from the at least one electrode and to determinewhether the electrical signal matches a predetermined criteria toauthenticate the identity of the user based on the electrical signal.

In another aspect, an authentication module is provided. Theauthentication module comprises at least one electrode configured tocouple an electrical signal associated with a user to a user of a targetauthentication device, the electrical signal represents anauthentication code for the target authentication device. Anauthentication transmission module is coupled to the at least oneelectrode. The authentication transmission module is configured totransmit the electrical signal from the at least one electrode.

In yet another aspect, a method of authenticating the identity of a userof a target authentication device is provided. According to the method,at least one electrode detects an electrical signal associated with auser of the target authentication device, the electrical signalrepresenting an authentication code for the target authenticationdevice. An authentication receiver module coupled to the at least oneelectrode receives the electrical signal from the at least oneelectrode. A processor determines whether the electrical signal matchesa predetermined criterion to authenticate the identity of the user basedon the electrical signal.

FIGURES

FIG. 1 illustrates a subject using a mobile device comprising electrodesfor detecting personal electrical signals from the body of the subject.

FIG. 2 illustrates one aspect of a mobile device comprising electrodesfor detecting electrical signals that can be employed to authenticatethe identity of the subject to enable the subject to get access to themobile device.

FIG. 3 is system diagram of one aspect of a mobile device configured todetect electrical signals for authenticating the identity of thesubject.

FIG. 4 is a block functional diagram of one aspect of an authenticationsubsystem for detecting and/or generating a transconductance signal toconfirm the identity of a person.

FIG. 5 illustrates one aspect of an ingestible event marker systemconfigured to generate a unique transconductance signal for confirmingthe identity of a person.

FIG. 6 illustrates one aspect of an authentication system comprising atarget authentication device and an authentication module comprising abody-associated device.

FIG. 7 illustrates one aspect of an authentication system comprising atarget authentication device and an authentication transmission modulecomprising an implantable body-associated device that is located belowthe skin of the subject.

FIG. 8 illustrates one aspect of an authentication system comprising atarget authentication device and an authentication transmission modulecomprising and an event marker system.

FIG. 9 is a block diagram representation of one aspect of the eventindicator system with dissimilar metals positioned on opposite ends.

FIG. 10 is a block diagram representation of another aspect of the eventindicator system with dissimilar metals positioned on the same end andseparated by a non-conducting material.

FIG. 11 shows ionic transfer or the current path through a conductingfluid when the event indicator system of FIG. 9 is in contact withconducting liquid and in an active state.

FIG. 11A shows an exploded view of the surface of dissimilar materialsof FIG. 11.

FIG. 11B shows the event indicator system of FIG. 11 with a pH sensorunit.

FIG. 12 is a block diagram illustration of one aspect of the controldevice used in the system of FIGS. 9 and 4**.

FIG. 13 is a functional block diagram of a demodulation circuit thatperforms coherent demodulation that may be present in a receiver,according to one aspect.

FIG. 14 illustrates a functional block diagram for a beacon modulewithin a receiver, according to one aspect.

FIG. 15 is a block diagram of the different functional modules that maybe present in a receiver, according to one aspect.

FIG. 16 is a block diagram of a receiver, according to one aspect.

FIG. 17 provides a block diagram of a high frequency signal chain in areceiver, according to one aspect.

FIG. 18A provides a diagram of how a system that includes a signalreceiver and an ingestible event marker may be employed, according toone aspect.

FIG. 18B provides a pharmaceutical delivery system that receives controlinformation form a receiver and control the dosage delivery.

FIG. 19 illustrates one aspect of mobile device received in a matingconfiguration with a mobile device enclosing arrangement comprising adetection circuit integrated therewith for detecting an electricalsignal generated by an ingestible event marker.

FIG. 20 illustrates the mobile device and the housing for receiving themobile device shown in FIG. 19 in an unmated configuration.

FIG. 21 illustrates one aspect of a housing for receiving a mobiledevice where the housing comprises a detection circuit for detecting anelectrical signal generated by an ingestible event marker integratedtherewith and a connector for electrically coupling the detectioncircuit to the functional modules of the mobile device.

DESCRIPTION

Before explaining the various aspects of authentication in detail, itshould be noted that the various aspects disclosed herein are notlimited in their application or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription. Rather, any disclosed aspect of authentication may bepositioned or incorporated in other aspects of authentication,variations, and modifications thereof, and may be practiced or carriedout in various ways. Accordingly, aspects of the authenticationapparatus, system, and method disclosed herein are illustrative innature and are not meant to limit the scope or application thereof.Furthermore, unless otherwise indicated, the terms and expressionsemployed herein have been chosen for the purpose of describing theaspects for the convenience of the reader and are not to limit the scopethereof. In addition, it should be understood that any one or more ofthe disclosed aspects, expressions of aspects, and/or examples thereof,can be combined with any one or more of the other disclosed aspects,expressions of aspects, and/or examples thereof, without limitation.

In the following description, like reference characters designate likeor corresponding parts throughout the several views. Also, in thefollowing description, it is to be understood that terms such as front,back, inside, outside, top, bottom and the like are words of convenienceand are not to be construed as limiting terms. Terminology used hereinis not meant to be limiting insofar as devices described herein, orportions thereof, may be attached or utilized in other orientations. Thevarious aspects will be described in more detail with reference to thedrawings.

The present disclosure is directed generally to various aspects ofauthentication by providing a physical connection between a user and atarget authentication device. One example of a target authenticationdevice is a computer system. As used herein, the term computer system inintended to encompass a broad category of devices including, withoutlimitation, computer networks, desktop computers, laptop computers,notebook computers, tablet computers, tablet computers, mobile phones,personal digital assistants, appliances, positioning systems, mediadevices, automatic teller machines (ATM), kiosks, and the like. Inaddition, authentication is required when entering public modes oftransportation (bus, train, subway, airplane, boat, rental car),building entrances, stadiums, turnstiles, and the like. Additionalcomputer systems that may require authentication also may includemedical systems that dispense medication in any form.

It will be appreciated that the term “medication” or “dose form” as usedthroughout this disclosure includes various forms of ingestible,inhalable, injectable, absorbable, or otherwise consumable medicamentsand/or carriers therefor such as, for example, pills, capsules, gelcaps, placebos, over capsulation carriers or vehicles, herbal,over-the-counter (OTC) substances, supplements, prescription-onlymedication, ingestible event markers (IEM), and the like.

Prior to describing various aspects of authentication techniques, thepresent disclosure first turns to FIG. 1 for a brief description of oneaspect of a system employing a sensing subsystem coupled to a subject,an event indicator system, and/or a body associated device by way of atleast one electrode. A subject can be person or thing that is requestingaccess to a target authentication device. The body associated device andthe event indicator system are configured to generate a uniqueelectrical current signal that is detectable by a detection subsystem.In addition, the detection subsystem may be configured to detect variousphysiological parameters associated with a living subject.

FIG. 1 illustrates a subject 100 using a mobile device 102 comprisingelectrodes 104 a, 104 b for detecting personal electrical signalsconducted through the body of the subject 100. In the illustratedexample, the mobile device 102 is the target authentication device. Themobile device 102 comprises electrodes 104 a, 104 b integrated into thehousing for detecting electrical signals coupled from the subject 100 tothe electrodes 104 a, 104 b. The term personal electrical signal is usedto indicate that a signal is intimately associated with the subject 100such that it can be used to confirm the identity of the subject 100 forpurposes of authentication. Personal electrical signals include, withoutlimitation, physiological signals associated with the subject, transbodyconductive signals generated by an ingestible event marker system 106,transbody conductive signals generated by a body-associated device 112,e.g., an adhesive patch that is applied on the body of the subject 100,any object in physical contact with the subject for example watch,bracelet, necklace, ring, etc. and/or transbody conductive signalsgenerated by an implanted body-associated device 113 that is locatedwithin the body of the subject 100. Physiological signals include,without limitation, skin impedance, electro cardiogram signals,conductively transmitted current signal, position of wearer,temperature, heart rate, perspiration rate, humidity, altitude/pressure,global positioning system (GPS), proximity, bacteria levels, glucoselevel, chemical markers, blood oxygen levels, among other physiologicaland physical parameters. Transbody conductive signals include, withoutlimitation, electrical currents that are transmitted through the body ofa subject, where the body acts as the conduction medium. In one aspect,transbody conductive signals can be generated by an ingestible eventmarker system 106, one example of which is described in connection withFIG. 5. In other aspects, transbody conductive signals can be generatedby electrical circuits placed in electrical contact with the surface ofthe skin of the subject 100 by way of a body-associated device 112. Inother aspects, transbody conductive signals can be generated byelectrical circuits implanted within the body of the subject 100.Additional aspects of mobile devices 102 configured for detecting anelectrical signal from an ingestible event marker system 106, amongothers, are described in commonly assigned International PCT ApplicationPCT/US/2012/047076, international publication number WO 2013/012869,which is herein incorporated by reference in its entirety.

Regardless of the source, the unique electrical signals suitable forauthentication are coupled to the target authentication device, e.g.,the mobile device 102, through at least one of the electrodes 104 a, 104b, which are suitable for sensing and sourcing electrical signals. Inoperation, the subject 100 holds the mobile device 102, or otherwisecontacts electrodes on another type of computer system, and physicallycontacts at least one of the electrodes 104 a, 104 b. The electricalsignals are coupled from the subject 100 through at least one of theelectrodes 104 a, 104 b to an authentication subsystem. Theauthentication subsystem can be integrated with the mobile device 102 ormay be added on.

When the ingestible event marker system 106 is the signal source, aunique electrical current signal is generated when the ingestible eventmarker system 106 contacts digestive fluids 108 in the stomach 110 ofthe subject 100. The unique electrical current signature is conductedthrough the body of the subject 100, is detected by at least one of theelectrodes 104 a, 104 b, and is coupled to an authentication subsystem,which decodes the signal and provides a decoded signal to a processingsubsystem to authenticate the subject 100.

When the body associated device 112 is the signal source, an electricalcurrent signal is generated by circuits in the body associated device112. The body associated device 112 is electrically coupled to the bodyof the subject 100 by another set of electrodes. The electrical signalis conducted by the body and detected by at least one of the inputelectrodes 104 a, 104 b on the mobile device 102. These and otheraspects of the personal authentication techniques are discussedhereinbelow. Prior to describing such systems, however, the disclosurenow turns to measurement subsystems for detecting electrical signals.

FIG. 2 illustrates one aspect of a mobile device 102 comprisingelectrodes 104 a, 104 b for detecting personal electrical signalssuitable for authenticating the identity of the subject 100. The mobiledevice 102 also comprises a housing 202, a display 204, an aperture 206for capturing digital images, and an antenna 208. The electrodes 104 a,104 b are located on the back of the housing 202 or at any convenientlocation of the mobile device 102. In one aspect, for example, theelectrodes 104 a, 104 b may be located on or embedded within a skin ordesign cover for a mobile device 102 as described hereinbelow inconnection with FIGS. 19-21.

FIG. 3 is a diagram of one aspect of a mobile device 102 configured fordetecting electrical signals for authenticating the identity of asubject 100. The mobile device 102 may comprise multiple elements.Although FIG. 3 shows a limited number of elements in a certain topologyby way of example, it can be appreciated that additional or fewerelements in any suitable topology may be used in the mobile device 102as desired for a given implementation. Furthermore, any element asdescribed herein may be implemented using hardware, software, or acombination of both, as previously described with reference to nodeimplementations. Aspects of the mobile device 102, however, are notlimited in this context.

In various aspects, in addition to a housing 202, a display 204, anaperture 206 for capturing digital images, and an antenna 208, themobile device 102 comprises a radio subsystem 302 connected via a bus toa processing subsystem 304. The radio subsystem 302 may perform voiceand data communications operations using wireless shared media for themobile device 102. The processing subsystem 304 may execute software forthe mobile device 102. A bus may comprise a USB or micro-USB bus andappropriate interfaces, as well as others.

In various aspects, an authentication and/or protection subsystem 306 iscoupled to the electrodes 104 a, 104 b. The electrodes 104 a, 104 b areconfigured to be in physical contact with the subject 100 (FIG. 1) toelectrically couple the unique electrical signals to and from theauthentication subsystem 306. When the subject 100 physically contactsat least one of the electrodes 104 a, 104 b the authentication subsystem306 can receive or transmit a unique electrical current signal forauthenticating the identity of the subject 100 and, once authenticated,providing access to the mobile device 102. Also, when the authenticationsubsystem 306 detects physiological signals associated with the subject100, the authentication subsystem 306 builds a database, which over timeprovides an average of the physiological signals associated with thesubject 100. Authentication occurs only when the detected physiologicalsignals match the running average physiological signals stored in thedatabase.

In various aspects, the detection subsystem 306 is coupled to theprocessing subsystem 304. The detection subsystem 306 converts thedetected electrical signals into a secret word or string of characters.A processing subsystem 304 coupled to the detection subsystem 306 usesthe string of characters for user authentication to prove identity ofthe subject 100 (FIG. 1) or for access approval to gain access to themobile device 102. When the subject 100 is authenticated, the processingsubsystem 304 activates the radio subsystem 304 and other functionalmodules of the computing device 102, such as, for example, an imagingsubsystem 308 or a navigation subsystem 310. When the subject 100 is notauthenticated, the processing subsystem 304 denies access to thefunctional modules of the mobile device 102 until the proper electricalsignals are detected by the detection subsystem 306.

In various aspects, the display 204 may comprise any suitable displayunit for displaying information appropriate for a mobile device 102. TheI/O system may comprise any suitable I/O device for entering informationinto the mobile device 102. Examples for the I/O system may include analphanumeric keyboard, a numeric keypad, a touch pad, a capacitive touchscreen panel, input keys, buttons, switches, rocker switches, voicerecognition device and software, and so forth. The I/O system maycomprise a microphone and speaker, for example. Information also may beentered into the mobile device 102 by way of the microphone. Suchinformation may be digitized by a voice recognition device.

In various aspects, the radio subsystem 320 may perform voice and datacommunications operations using wireless shared media for the mobiledevice 102. The processing subsystem 304 may execute software for themobile device 102. A bus may comprise a universal serial bus (USB),micro-USB bus, dataport, and appropriate interfaces, as well as others.In one aspect the radio subsystem 302 may be arranged to communicatevoice information and control information over one or more assignedfrequency bands of the wireless shared media.

In various aspects, the imaging subsystem 308 processes images capturedthrough the aperture 206. A camera may be coupled (e.g., wired orwirelessly) to the processing subsystem 304 and is configured to outputimage data (photographic data of a person or thing, e.g., video data,digital still image data) to the processing subsystem 304 and to thedisplay 204. In one aspect, the imaging subsystem 308 may comprise adigital camera implemented as an electronic device used to capture andstore images electronically in a digital format. Additionally, in someaspects the digital camera may be capable of recording sound and/orvideo in addition to still images.

In various aspects, the imaging subsystem 308 may comprise a controllerto provide control signals to components of a digital camera, includinglens position component, microphone position component, and a flashcontrol module, to provide functionality for the digital camera. In someaspects, the controller may be implemented as, for example, a hostprocessor element of the processing subsystem 304 of the mobile device102. Alternatively, the imaging controller may be implemented as aseparate processor from the host processor.

In various aspects, the imaging subsystem 308 may comprise memory eitheras an element of the processing subsystem 304 of the mobile device 102or as a separate element. It is worthy to note that in various aspectssome portion or the entire memory may be included on the same integratedcircuit as the controller. Alternatively, some portion or the entirememory may be disposed on an integrated circuit or other medium (e.g.,hard disk drive) external to the integrated circuit of the controller.

In various aspects, the aperture 206 includes a lens component and alens position component. The lens component may consist of aphotographic or optical lens or arrangement of lenses made of atransparent material such as glass, plastic, acrylic or Plexiglass, forexample. In one aspect, the one or more lens elements of the lenscomponent may reproduce an image of an object and allow for zooming inor out on the object by mechanically changing the focal length of thelens elements. In various aspects, a digital zoom may be employed in theimaging subsystem 308 to zoom in or out on an image. In some aspects,the one or more lens elements may be used to focus on different portionsof an image by varying the focal length of the lens elements. Thedesired focus can be obtained with an autofocus feature of the digitalimaging subsystem 308 or by manually focusing on the desired portion ofthe image, for example.

In various aspects, the navigation subsystem 310 supports navigationusing the mobile device 102. In various aspects the mobile device 102may comprise location or position determination capabilities and mayemploy one or more location determination techniques including, forexample, Global Positioning System (GPS) techniques, Cell GlobalIdentity (CGI) techniques, CGI including timing advance (TA) techniques,Enhanced Forward Link Trilateration (EFLT) techniques, Time Differenceof Arrival (TDOA) techniques, Angle of Arrival (AOA) techniques,Advanced Forward Link Trilateration (AFTL) techniques, Observed TimeDifference of Arrival (OTDOA), Enhanced Observed Time Difference (EOTD)techniques, Assisted GPS (AGPS) techniques, hybrid techniques (e.g.,GPS/CGI, AGPS/CGI, GPS/AFTL or AGPS/AFTL for CDMA networks, GPS/EOTD orAGPS/EOTD for GSM/GPRS networks, GPS/OTDOA or AGPS/OTDOA for UMTSnetworks), among others.

In various aspects, the mobile device 102 may be configured to operatein one or more location determination modes including, for example, astandalone mode, a mobile station (MS) assisted mode, and/or a MS-basedmode. In a standalone mode, such as a standalone GPS mode, the mobiledevice 102 may be configured to determine its position without receivingwireless navigation data from the network, though it may receive certaintypes of position assist data, such as almanac, ephemeris, and coarsedata. In a standalone mode, the mobile device 102 may comprise a locallocation determination circuit such as a GPS receiver which may beintegrated within the housing 202 configured to receive satellite datavia the antenna 208 and to calculate a position fix. Local locationdetermination circuit may alternatively comprise a GPS receiver in asecond housing separate from the housing 202 but in the vicinity of themobile device 102 and configured to communicate with the mobile device102 wirelessly (e.g., via a PAN, such as Bluetooth). When operating inan MS-assisted mode or an MS-based mode, however, the mobile device 102may be configured to communicate over a radio access network (e.g., UMTSradio access network) with a remote computer (e.g., a locationdetermination entity (LDE), a location proxy server (LPS) and/or amobile positioning center (MPC), among others).

In various aspects, the mobile device 102 also may comprise a powermanagement subsystem (not shown) to manage power for the mobile device102, including the radio subsystem 302, the processing subsystem 304,and other elements of the mobile device 102. For example, the powermanagement subsystem may include one or more batteries to provide directcurrent (DC) power, and one or more alternating current (AC) interfacesto draw power from a standard AC main power supply.

In various aspects, the radio subsystem 302 may include an antenna 208.The antenna 208 may broadcast and receive RF energy over the wirelessshared media. Examples for the antenna 208 may include an internalantenna, an omni-directional antenna, a monopole antenna, a dipoleantenna, an end fed antenna, a circularly polarized antenna, amicro-strip antenna, a diversity antenna, a dual antenna, an antennaarray, a helical antenna, and so forth. The aspects are not limited inthis context.

In various aspects, the antenna 208 may be connected to a multiplexer.The multiplexer multiplexes signals from a power amplifier for deliveryto the antenna 208. The multiplexer demultiplexes signals received fromthe antenna for delivery to an RF chipset.

In various aspects, the multiplexer may be connected to a poweramplifier, where the power amplifier may be used to amplify any signalsto be transmitted over the wireless shared media. The power amplifiermay work in all assigned frequency bands, such as four (4) frequencybands in a quad-band system. The power amplifier also may operate invarious modulation modes, such as Gaussian Minimum Shift Keying (GMSK)modulation suitable for GSM systems and 8-ary Phase Shift Keying (8-PSK)modulation suitable for EDGE systems.

In various aspects, the power amplifier may be connected to an RFchipset. The RF chipset also may be connected to the multiplexer. In oneaspect, the RF chipset may comprise an RF driver and an RF transceiver.The RF chipset performs all of the modulation and direct conversionoperations required for GMSK and 8-PSK signal types for quad-band E-GPRSradio. The RF chipset receives analog in-phase (I) and quadrature (Q)signals from a baseband processor, and converts the I/Q signals to an RFsignal suitable for amplification by the power amplifier. Similarly, theRF chipset converts the signals received from the wireless shared mediavia the antenna 208 and the multiplexer to analog I/Q signals to be sentto the baseband processor. Although the RF chipset may use two chips byway of example, it may be appreciated that the RF chipset may beimplemented using more or less chips and still fall within the intendedscope of the aspects.

In various aspects, the RF chipset may be connected to the basebandprocessor, where the baseband processor may perform baseband operationsfor the radio subsystem 514. The baseband processor may comprise bothanalog and digital baseband sections. The analog baseband sectionincludes I/Q filters, analog-to-digital converters, digital-to-analogconverters, audio circuits, and other circuits. The digital basebandsection may include one or more encoders, decoders,equalizers/demodulators, GMSK modulators, GPRS ciphers, transceivercontrols, automatic frequency control (AFC), automatic gain control(AGC), power amplifier (PA) ramp control, and other circuits.

In various aspects, the baseband processor also may be connected to oneor more memory units via a memory bus. In one aspect, for example, thebaseband processor may be connected to a flash memory unit and a securedigital (SD) memory unit. The memory units may be removable ornon-removable memory. In one aspect, for example, the baseband processormay use approximately 1.6 megabytes of static read-only memory (SRAM)for E-GPRS and other protocol stack needs.

In various aspects, the baseband processor also may be connected to asubscriber identity module (SIM). The baseband processor may have a SIMinterface for the SIM, where the SIM may comprise a smart card thatencrypts voice and data transmissions and stores data about the specificuser so that the user can be identified and authenticated to the networksupplying voice or data communications. The SIM also may store data suchas personal phone settings specific to the user and phone numbers. TheSIM can be removable or non-removable.

In various aspects, the baseband processor may further include variousinterfaces for communicating with a host processor of the processingsubsystem 304. For example, the baseband processor may have one or moreuniversal asynchronous receiver-transmitter (UART) interfaces, one ormore control/status lines to the host processor, one or morecontrol/data lines to the host processor, and one or more audio lines tocommunicate audio signals to an audio subsystem of processing subsystem514. The aspects are not limited in this context.

In various aspects, the processing subsystem 304 may provide computingor processing operations for the mobile device 102 and/or for theauthentication subsystem 306. For example, the processing subsystem 304may be arranged to execute various software programs for the mobiledevice 102 as well as several software programs for the authenticationsubsystem 306. Although the processing subsystem 304 may be used toimplement operations for the various aspects as software executed by aprocessor, it may be appreciated that the operations performed by theprocessing subsystem 304 also may be implemented using hardware circuitsor structures, or a combination of hardware and software, as desired fora particular implementation.

In various aspects, the processing subsystem 304 may include a processorimplemented using any processor or logic device, such as a complexinstruction set computer (CISC) microprocessor, a reduced instructionset computing (RISC) microprocessor, a very long instruction word (VLIW)microprocessor, a processor implementing a combination of instructionsets, or other processor device. In one aspect, for example, a processormay be implemented as a general purpose processor, such as a processormade by Intel Corporation, Santa Clara, Calif. The processor also may beimplemented as a dedicated processor, such as a controller,microcontroller, embedded processor, a digital signal processor (DSP), anetwork processor, a media processor, an input/output (I/O) processor, amedia access control (MAC) processor, a radio baseband processor, afield programmable gate array (FPGA), a programmable logic device (PLD),and so forth.

In one aspect, the processing subsystem 304 may include a memory toconnect to the processor. The memory may be implemented using anymachine-readable or computer-readable media capable of storing data,including both volatile and non-volatile memory. For example, the memorymay include ROM, RAM, DRAM, DDRAM, SDRAM, SRAM, PROM, EPROM, EEPROM,flash memory, polymer memory such as ferroelectric polymer memory,ovonic memory, phase change or ferroelectric memory,silicon-oxide-nitride-oxide-silicon (SONOS) memory, magnetic or opticalcards, or any other type of media suitable for storing information. Itis worthy to note that some portion or all of the memory may be includedon the same integrated circuit as the processor thereby obviating theneed for a memory bus. Alternatively some portion or all of the memorymay be disposed on an integrated circuit or other medium, for example ahard disk drive, that is external to the integrated circuit of theprocessor, and the processor may access the memory via a memory bus, forexample.

In various aspects, the memory may store one or more software components(e.g., application client modules). A software component may refer toone or more programs, or a portion of a program, used to implement adiscrete set of operations. A collection of software components for agiven device may be collectively referred to as a software architectureor application framework. A software architecture for the mobile device102 is described in more detail below.

A software architecture suitable for use with the mobile device 102 mayinclude a user interface (UI) module, an interface module, a data sourceor backend services module (data source), and a third party API module.An optional LBS module may comprise a user based permission module, aparser module (e.g., National Maritime Electronic Association or NMEA),a location information source module, and a position information sourcemodule. In some aspects, some software components may be omitted andothers added. Further, operations for some programs may be separatedinto additional software components, or consolidated into fewer softwarecomponents, as desired for a given implementation. The mobile device 102software architecture may comprise several elements, components ormodules, collectively referred to herein as a “module.” A module may beimplemented as a circuit, an integrated circuit, an application specificintegrated circuit (ASIC), an integrated circuit array, a chipsetcomprising an integrated circuit or an integrated circuit array, a logiccircuit, a memory, an element of an integrated circuit array or achipset, a stacked integrated circuit array, a processor, a digitalsignal processor, a programmable logic device, code, firmware, software,and any combination thereof.

Having described the mobile device 102 as one example of computersystem, it will be appreciated that any of the following computersystems, without limitation, computer networks, desktop computers,laptop computers, notebook computers, tablet computers, tabletcomputers, mobile phones, personal digital assistants, appliances,positioning systems, media devices, automatic teller machines (ATM),kiosks, public modes of transportation (bus, train, subway, airplane,boat, rental car, . . . ), building entrances, stadiums, turnstiles,medical systems that dispense medication in any form could be equippedwith at least one electrode and a detection subsystem to authenticatethe user as the owner of the computer system for security purposes. Forthe sake of conciseness and clarity, not all of these computer systemswill be discussed here.

Turning briefly now to FIGS. 19-21, which illustrate aspects of a mobiledevice 1100 received in a mating configuration with a mobile deviceenclosing arrangement 1102 comprising a detection circuit integratedtherewith for detecting an electrical signal generated by an ingestibleevent marker, such as the IEM device, otherwise referred to herein as aningestible event marker system 106, for example. They can be made ofhard plastic or in the newer market adhesive-backed vinyl pieces. FIG.19 illustrates one aspect of a mobile device 1100 received in a matingconfiguration with a mobile device enclosing arrangement 1102 comprisinga detection circuit integrated therewith for detecting an electricalsignal generated by an ingestible event marker system 106, for example.

The enclosing arrangement 1102 may be referred to as a housing,enclosure, attachment, skin, design cover, among other accessories formobile devices, and may substantially or partially cover or enclose themobile device 1100. FIG. 20 illustrates the mobile device 1100 and theenclosing arrangement 1102 (cradle, protective cover, skin, and thelike) for receiving the mobile device 1100 in an unmated configuration.The mobile device 1100 shown in FIGS. 19 and 20 is substantially similarto the mobile devices 102 and others described hereinbefore and,therefore, a high level description of similar functional modules willnot be repeated here for the sake of conciseness and clarity ofdisclosure.

As shown in FIGS. 19 and 20, the mobile device 1100 is configured tomate with the enclosing arrangement 1102. The enclosing arrangement 1102contains a detection module 1200 integrated therewith. The detectionmodule 1200 comprises a detection subsystem comprising an electrodeinput circuit similar to the detection subsystem 516 and electrode inputcircuit shown in FIG. 4 as electrode input/output interface circuit 401.Due to the similarity of the detection subsystem and electrode inputcircuit components, the particular details will not be repeated here forthe sake of conciseness and clarity of disclosure. The enclosingarrangement 1102 also includes electrodes 1202A and 1202B (not shown inFIG. 20 and shown in FIG. 21) to couple the patient to the detectionmodule 1200. The detection module 1200 may be electrically coupled tofunctional modules of the mobile device 1100 to detect and process theunique electrical signature generated by the ingestible event markersystem 106 (e.g., IEM device). The detection module 1200 may beelectrically coupled to the functional modules of the mobile device 1100using any suitable techniques such as, for example, inductive coupling,wireless transmission, electrical connector, and the like. One exampleof a housing comprising a suitable connector to electrically couple thedetection module 1200 to the functional modules of the mobile device1100 is described in connection with FIG. 21.

FIG. 21 illustrates one aspect of a enclosing arrangement 1102 forreceiving a mobile device where the enclosing arrangement 1102 comprisesa detection circuit 1200 for detecting an electrical signal generated byan ingestible event marker integrated therewith and a connector 1300 forelectrically coupling the detection circuit 1200 to the functionalmodules of the mobile device. In use, the mobile device (not shown) isslidably inserted over the enclosing arrangement 1102 and plugged intothe connector 1300. The electrodes 1202A, 1202B are used tot couple thepatient to the detection module 1200. The connector 1300 couples thedetection module 1200 to the functional modules of the mobile device1100 (FIG. 20) for communication purposes, among other purposes. In oneaspect, the detection module 1200 integrated with the enclosingarrangement 1102 is a standalone module and includes all the necessaryelectronic modules to detect the unique electrical current signaturegenerated by the IEM device.

Turning now back to FIG. 4, which is a block functional diagram of oneaspect of an authentication subsystem 306 for detecting and/orgenerating personal electrical signals to authenticate the user andprove the identity of the subject 100 (FIG. 1). The authenticationsubsystem 306 comprises an electrode input/output interface circuit 401to receive/transmit electrical signals from/to the electrodes 104 a, 104b. The authentication subsystem 306 can be configured to operate inreceive mode, broadcast mode, or combinations thereof. In receive mode,the input/output interface circuit 401 receives electrical signals fromthe electrodes 104 a, 104 b. In broadcast mode, the input/outputinterface circuit 401 transmits electrical signals to the electrodes 104a, 104 b.

A transbody conductive communication module 402 and a physiologicalsensing module 404 are electrically coupled to the electrodeinput/output interface circuit 401. In one aspect, the transbodyconductive communication module 402 is implemented as a first, e.g.,high, frequency (HF) signal chain and the physiological sensing module404 is implemented as a second, e.g., low, frequency (LF) signal chain.Also shown are CMOS temperature sensing module 406 (for detectingambient temperature) and a 3-axis accelerometer 408. The authenticationsubsystem 306 also comprises a processing engine 418 (for example, amicrocontroller and digital signal processor), a non-volatile memory 410(for data storage), and a wireless communication module 412 to receivedata from and/or transmit data to another device, for example in a datadownload/upload action, respectively. In various aspects, thecommunication module 412 may comprise one or more transmitters/receivers(“transceiver”) modules. As used herein, the term “transceiver” may beused in a very general sense to include a transmitter, a receiver, or acombination of both, without limitation. In one aspect, the transbodyconductive communication module 402 is configured to communicate with aningestible event marker system 106 (FIGS. 1, 5). In receive mode, thetransbody conductive communication module 402 is configured to receive atransconduction current signal from the subject 100 (FIG. 1) via atleast one of the electrodes 104 a, 104 b (FIG. 1). In broadcast mode,the transbody conductive communication module 402 is configured totransmit a transconduction current signal to the subject 100 via atleast one of the electrodes 104 a, 104 b (FIG. 1). In one aspect, thetransbody conductive communication module 402 is configured as a skin ordesign cover for a mobile device.

The sensors 414 typically contact the subject 100 (FIG. 1), e.g., areremovably attachable to the torso. In various aspects, the sensors 414may be removably or permanently attached to the authentication subsystem306. For example, the sensors 414 may be removably connected to anotherdevice by snapping metal studs. The sensors 414 may comprise, forexample, various devices capable of sensing or receiving the physiologicdata. The types of sensors 414 include, for example, electrodes such asbiocompatible electrodes. The sensors 414 may be configured, forexample, as a pressure sensor, a motion sensor, an accelerometer, anelectromyography (EMG) sensor, an event marker system, a biopotentialsensor, an electrocardiogram sensor, a temperature sensor, a tactileevent marker sensor, and an impedance sensor.

The feedback module 416 may be implemented with software, hardware,circuitry, various devices, and combinations thereof. The function ofthe feedback module 416 is to provide communication with the subject 100(FIG. 1) in a discreet, tactful, circumspect manner as described above.In various aspects the feedback module 416 may be implemented tocommunicate with the subject 100 using techniques that employ visual,audio, vibratory/tactile, olfactory, and taste.

FIG. 5 illustrates one aspect of an ingestible event marker system 106configured to generate a unique transconductance signal for confirmingthe identity of a person. In various aspects the ingestible event markersystem 106 can be used in association with any medication product, asmentioned above, to determine the origin of the medication and toconfirm that at least one of the right type and the right dosage ofmedication was delivered to the patient and in some aspects to determinewhen a patient takes the medication product. The scope of the presentdisclosure, however, is not limited by the environment and themedication product that may be used with the system 106. For example,the system 106 may be activated either in wireless mode, in galvanicmode by placing the system 106 within a capsule and then placing thecapsule within a conducting fluid, or a combination thereof, or exposingthe system 106 to air. Once placed in a conducting fluid, for example,the capsule would dissolve over a period of time and release the system106 into the conducting fluid. Thus, in one aspect, the capsule wouldcontain the system 106 and no product. Such a capsule may then be usedin any environment where a conducting fluid is present and with anyproduct. For example, the capsule may be dropped into a container filledwith jet fuel, salt water, tomato sauce, motor oil, or any similarproduct. Additionally, the capsule containing the system 106 may beingested at the same time that any pharmaceutical product is ingested inorder to record the occurrence of the event, such as when the productwas taken.

In the specific example of the system 106 combined with a medication orpharmaceutical product, as the product or pill is ingested, or exposedto air, the system 106 is activated in galvanic mode. The system 106controls conductance to produce a unique current signature that isdetected by the electrodes 104 a, 104 b (FIGS. 1-4), for example,thereby transmitting a unique transconduction signal that authenticatesthe user as the owner of the computer system (e.g., the mobile device102). When activated in wireless mode, the system controls modulation ofcapacitive plates to produce a unique voltage signature associated withthe system 106 that is detected.

In one aspect, the system 106 includes a framework 502. The framework502 is a chassis for the system 106 and multiple components are attachedto, deposited upon, or secured to the framework 502. In this aspect ofthe system 106, a digestible material 504 is physically associated withthe framework 502. The material 504 may be chemically deposited on,evaporated onto, secured to, or built-up on the framework all of whichmay be referred to herein as “deposit” with respect to the framework502. The material 504 is deposited on one side of the framework 502. Thematerials of interest that can be used as material 504 include, but arenot limited to: Cu, CuCl, or CuI. The material 504 is deposited byphysical vapor deposition, electrodeposition, or plasma deposition,among other protocols. The material 504 may be from about 0.05 to about500 μm thick, such as from about 5 to about 100 μm thick. The shape iscontrolled by shadow mask deposition, or photolithography and etching.Additionally, even though only one region is shown for depositing thematerial, each system 106 may contain two or more electrically uniqueregions where the material 504 may be deposited, as desired.

At a different side, which is the opposite side as shown in FIG. 5,another digestible material 506 is deposited, such that the materials504, 506 are dissimilar and insulated from each other. Although notshown, the different side selected may be the side next to the sideselected for the material 504. The scope of the present disclosure isnot limited by the side selected and the term “different side” can meanany of the multiple sides that are different from the first selectedside. In various aspects, the dissimilar material may be located atdifferent positions on a same side. Furthermore, although the shape ofthe system is shown as a square, the shape may be any geometricallysuitable shape. The materials 504, 506 are selected such that theyproduce a voltage potential difference when the system 106 is in contactwith conducting liquid, such as body fluids. The materials of interestfor material 506 include, but are not limited to: Mg, Zn, or otherelectronegative metals. As indicated above with respect to the material504, the material 506 may be chemically deposited on, evaporated onto,secured to, or built-up on the framework. Also, an adhesion layer may benecessary to help the material 506 (as well as material 504 when needed)to adhere to the framework 502. Typical adhesion layers for the material506 are Ti, TiW, Cr or similar material. Anode material and the adhesionlayer may be deposited by physical vapor deposition, electrodepositionor plasma deposition. The material 506 may be from about 0.05 to about500 μm thick, such as from about 5 to about 100 μm thick. However, thescope of the present disclosure is not limited by the thickness of anyof the materials nor by the type of process used to deposit or securethe materials to the framework 502.

According to the disclosure set forth, the materials 504, 506 can be anypair of materials with different electrochemical potentials.Additionally, in the aspects wherein the system 106 is used in-vivo, thematerials 504, 506 may be vitamins that can be absorbed. Morespecifically, the materials 504, 506 can be made of any two materialsappropriate for the environment in which the system 106 will beoperating. For example, when used with an ingestible product, thematerials 504, 506 are any pair of materials with differentelectrochemical potentials that are ingestible. An illustrative exampleincludes the instance when the system 106 is in contact with an ionicsolution, such as stomach acids, fluids excreted through the surface ofthe skin, fluids present below the surface of the skin, for example.Suitable materials are not restricted to metals, and in certain aspectsthe paired materials are chosen from metals and non-metals, e.g., a pairmade up of a metal (such as Mg) and a salt (such as CuCl or CuI). Withrespect to the active electrode materials, any pairing ofsubstances—metals, salts, or intercalation compounds—with suitablydifferent electrochemical potentials (voltage) and low interfacialresistance are suitable.

Materials and pairings of interest include, but are not limited to,those reported in TABLE 1 below. In one aspect, one or both of themetals may be doped with a non-metal, e.g., to enhance the voltagepotential created between the materials as they come into contact with aconducting liquid. Non-metals that may be used as doping agents incertain aspects include, but are not limited to: sulfur, iodine, and thelike. In another aspect, the materials are copper iodine (CuI) as theanode and magnesium (Mg) as the cathode. Aspects of the presentdisclosure use electrode materials that are not harmful to the humanbody.

TABLE 1 Anode Cathode Metals Magnesium, Zinc Sodium (†), Lithium (†)Iron Salts Copper salts: iodide, chloride, bromide, sulfate, formate,(other anions possible) Fe³⁺ salts: e.g. orthophosphate, pyrophosphate,(other anions possible) Oxygen (††) on platinum, gold or other catalyticsurfaces Intercalation Graphite with Li, Vanadium oxide Manganese oxidecompounds K, Ca, Na, Mg

Thus, when the system 106 is in contact with the conducting fluid, acurrent path is formed through the conducting fluid between thedissimilar materials 504, 506. A control device 508 is secured to theframework 502 and electrically coupled to the materials 504, 506. Thecontrol device 508 includes electronic circuitry, for example controllogic that is capable of controlling and altering the conductancebetween the materials 504, 506.

The voltage potential created between the dissimilar materials 504, 506provides the power for operating the system as well as produces thecurrent flow through the conducting fluid and the system 106. In oneaspect, the system 106 operates in direct current mode. In analternative aspect, the system 106 controls the direction of the currentso that the direction of current is reversed in a cyclic manner, similarto alternating current. As the system reaches the conducting fluid orthe electrolyte, where the fluid or electrolyte component is provided bya physiological fluid, e.g., stomach acid, the path for current flowbetween the dissimilar materials 504, 506 is completed external to thesystem 106; the current path through the system 106 is controlled by thecontrol device 508. Completion of the current path allows for thecurrent to flow and in turn a receiver, not shown, can detect thepresence of the current and recognize that the system 106 has beenactivate and the desired event is occurring or has occurred.

In one aspect, the two dissimilar materials 504, 506 are similar infunction to the two electrodes needed for a direct current power source,such as a battery. The conducting liquid acts as the electrolyte neededto complete the power source. The completed power source described isdefined by the physical chemical reaction between the dissimilarmaterials 504, 506 of the system 106 and the surrounding fluids of thebody. The completed power source may be viewed as a power source thatexploits reverse electrolysis in an ionic or a conduction solution suchas gastric fluid, blood, or other bodily fluids and some tissues.Additionally, the environment may be something other than a body and theliquid may be any conducting liquid. For example, the conducting fluidmay be salt water or a metallic based paint.

In certain aspects, the two dissimilar materials 504, 506 are shieldedfrom the surrounding environment by an additional layer of material.Accordingly, when the shield is dissolved and the two dissimilarmaterials 504, 506 are exposed to the target site, a voltage potentialis generated.

In certain aspects, the complete power source or supply is one that ismade up of active electrode materials, electrolytes, and inactivematerials, such as current collectors, packaging. The active materialsare any pair of materials with different electrochemical potentials.Suitable materials are not restricted to metals, and in certain aspectsthe paired materials are chosen from metals and non-metals, e.g., a pairmade up of a metal (such as Mg) and a salt (such as CuI). With respectto the active electrode materials, any pairing of substances—metals,salts, or intercalation compounds—with suitably differentelectrochemical potentials (voltage) and low interfacial resistance aresuitable.

A variety of different materials may be employed as the materials thatform the electrodes. In certain aspects, electrode materials are chosento provide for a voltage upon contact with the target physiologicalsite, e.g., the stomach, sufficient to drive the system of theidentifier. In certain aspects, the voltage provided by the electrodematerials upon contact of the metals of the power source with the targetphysiological site is 0.001 V or higher, including 0.01 V or higher,such as 0.1 V or higher, e.g., 0.3 V or higher, including 0.5 volts orhigher, and including 1.0 volts or higher, where in certain aspects, thevoltage ranges from about 0.001 to about 10 volts, such as from about0.01 to about 10 V.

Referring still to FIG. 5, the dissimilar materials 504, 506 provide thevoltage potential to activate the control device 508. Once the controldevice 508 is activated or powered up, the control device 508 can alterconductance between the first and second materials 504, 506 in a uniquemanner. By altering the conductance between the first and secondmaterials 504, 506, the control device 508 is capable of controlling themagnitude of the current through the conducting liquid that surroundsthe system 106. This produces a unique current signature that can bedetected and measured by a receiver (not shown), which can be positionedinternal or external to the body. The receiver is disclosed in greaterdetail in U.S. patent application Ser. No. 12/673,326 entitled“BODY-ASSOCIATED RECEIVER AND METHOD” filed on Dec. 15, 2009, andpublished as 2010-0312188 A1 dated Dec. 9, 2010 which is incorporatedherein by reference in its entirety. In addition to controlling themagnitude of the current path between the materials, non-conductingmaterials, membrane, or “skirt” are used to increase the “length” of thecurrent path and, hence, act to boost the conductance path, as disclosedin the U.S. patent application Ser. No. 12/238,345 entitled, “IN-BODYDEVICE WITH VIRTUAL DIPOLE SIGNAL AMPLIFICATION” filed Sep. 25, 2008,the entire content of which is incorporated herein by reference.Alternatively, throughout the disclosure herein, the terms“non-conducting material,” “membrane,” and “skirt” are interchangeablyused with the term “current path extender” without impacting the scopeor the present aspects and the claims herein. The skirt, shown inportion at 505, 507, respectively, may be associated with, e.g., securedto, the framework 502. Various shapes and configurations for the skirtare contemplated as within the scope of the various aspects of thepresent invention. For example, the system 106 may be surroundedentirely or partially by the skirt and the skirt maybe positioned alonga central axis of the system 106 or off-center relative to a centralaxis. Thus, the scope of the present invention as claimed herein is notlimited by the shape or size of the skirt. Furthermore, in otheraspects, the dissimilar materials 504, 506 may be separated by one skirtthat is positioned in any defined region between the dissimilarmaterials 504, 506.

The system 106 may be grounded through a ground contact. The system 106also may include a sensor module. In operation, ion or current paths areestablished between the first material 504 to the second material 506and through a conducting fluid in contact with the system 106. Thevoltage potential created between the first and second materials 504,506 is created through chemical reactions between the first and secondmaterials 504, 506 and the conducting fluid. In one aspect, the surfaceof the first material 504 is not planar, but rather an irregularsurface. The irregular surface increases the surface area of thematerial and, hence, the area that comes in contact with the conductingfluid.

In one aspect, at the surface of the first material 504, there ischemical reaction between the material 504 and the surroundingconducting fluid such that mass is released into the conducting fluid.The term mass as used herein refers to protons and neutrons that form asubstance. One example includes the instant where the material is CuCland when in contact with the conducting fluid, CuCl becomes Cu (solid)and Cl— in solution. The flow of ions into the conduction fluid is viaion paths. In a similar manner, there is a chemical reaction between thesecond material 506 and the surrounding conducting fluid and ions arecaptured by the second material 506. The release of ions at the firstmaterial 504 and capture of ion by the second material 506 iscollectively referred to as the ionic exchange. The rate of ionicexchange and, hence the ionic emission rate or flow, is controlled bythe control device 508. The control device 508 can increase or decreasethe rate of ion flow by altering the conductance, which alters theimpedance, between the first and second materials 504, 506. Throughcontrolling the ion exchange, the system 106 can encode information inthe ionic exchange process. Thus, the system 106 uses ionic emission toencode information in the ionic exchange.

The control device 508 can vary the duration of a fixed ionic exchangerate or current flow magnitude while keeping the rate or magnitude nearconstant, similar to when the frequency is modulated and the amplitudeis constant. Also, the control device 508 can vary the level of theionic exchange rate or the magnitude of the current flow while keepingthe duration near constant. Thus, using various combinations of changesin duration and altering the rate or magnitude, the control device 508encodes information in the current flow or the ionic exchange. Forexample, the control device 508 may use, but is not limited to any ofthe following techniques namely, Binary Phase-Shift Keying (PSK),Frequency Modulation (FM), Amplitude Modulation (AM), On-Off Keying, andPSK with On-Off Keying.

Various aspects of the system 106 may comprise electronic components aspart of the control device 508. Components that may be present includebut are not limited to: logic and/or memory elements, an integratedcircuit, an inductor, a resistor, and sensors for measuring variousparameters. Each component may be secured to the framework and/or toanother component. The components on the surface of the support may belaid out in any convenient configuration. Where two or more componentsare present on the surface of the solid support, interconnects may beprovided.

The system 106 controls the conductance between the dissimilar materialsand, hence, the rate of ionic exchange or the current flow. Throughaltering the conductance in a specific manner the system is capable ofencoding information in the ionic exchange and the current signature.The ionic exchange or the current signature is used to uniquely identifythe specific system. Additionally, the system 106 is capable ofproducing various different unique exchanges or signatures and, thus,provides additional information. For example, a second current signaturebased on a second conductance alteration pattern may be used to provideadditional information, which information may be related to the physicalenvironment. To further illustrate, a first current signature may be avery low current state that maintains an oscillator on the chip and asecond current signature may be a current state at least a factor of tenhigher than the current state associated with the first currentsignature.

Having now described the basic elements of a personal authenticationsystem, the disclosure now turns to a description of various aspects ofauthentication systems. FIG. 6 illustrates one aspect of anauthentication system 600 comprising a target authentication device 602and an authentication module comprising a body-associated device 112.The target authentication device 602 comprises an authenticationreceiver module 601. The body-associated device 112 comprises atransmission device 603. In one embodiment, the body-associated device112 is destroyed when it is removed from the body of the subject 100.

The body-associated device 112 is located on the surface of the skin andis electrically coupled to the subject 100 via electrodes 604 a, 604 b.In one aspect, the body-associated device 112 comprises a transmissiondevice 603 that is configured, or programmed, with a secret code 606that is stored in memory 608, such as a password or a private key formore sophisticated authentication mechanisms. The body-associated device112 acts in broadcast mode (opposite to the receive mode). The secretcode 606 is read from the memory 608 and is encoded into a signal 610 byan encoder 612. The encoded signal 610 is converted to an electricallyconductive signal 614 by the I/O interface circuit 616. The encodedelectrically conductive signal 614 is applied to the body 617 of thesubject 100 via the electrodes 604 a, 604 b. A battery V_(batt) may beincluded in the body-associated device as a power source. Alternatively,a power source may be implemented by coupling energy through theelectrodes 604 a, 604 b from the target authentication device 602. Inyet another alternative, a power source similar to the power sourcedescribed in connection with the ingestible event marker 106 (FIG. 5)may be employed where the power source may be activated by fluidexcreted on the surface of the skin of the subject 100.

The electrically conductive signal 614 is conducted through the body 617of the subject 100 to the authentication receiver module 601 of thetarget authentication device 602. Electrodes 618 a, 618 b detect theelectrically conductive signal 614 from the body 617 and are coupled toa decoder 619 though an I/O interface circuit 620. The decoder 619decodes the electrically conductive signal 614. The decoded code 622 isthen compared by compare module 624 to established criteria 626. Whenthe code 622 matches the established criteria 626, compare module 624provides the results to the processor 628, which determines whether theelectrical signal matches the predetermined criteria to authenticate theidentity of the user based on the an electrical signal. If a matchoccurs, the processor 629 unlocks the target authentication device 602and enables access by the subject 100. In one aspect, the authenticationreceiver module 601 is configured to encode the detected signal with asecret and retransmit the encoded signal back to the receiver modulewhere it is compared to an expected result dependent on the mathematicalproperties of the encoding and the secret. In one aspect, theauthentication receiver module 601 is configured to authenticate achallenge-response authentication, which is an authentication processthat verifies an identity by requiring correct authenticationinformation to be provided in response to a challenge. Theauthentication information may be usually a value that is computed inresponse to an unpredictable challenge value, but it may be just apassword.

The target authentication device 602 may be any number of digitalinstruments. As previously discussed, the target authentication device602 may be a mobile device 102 as described in connection with FIGS.1-3. In other aspects, the target authentication device 602 may be anyof the computer systems identified above. In one aspect, the targetauthentication device 602 may be located on a keyboard to ensure theidentity of the user when the hands touch the keyboard, allowing thesubject 100 to authenticate against web sites; a check-out terminal,which authenticates against the bank account of the subject 100 andallows the subject 100 to pay for transactions; a car that knows thesubject 100 is the one holding the steering wheel and starts only forthe subject 100; a doorknob that unlocks when authorized subjects 100touch it; the target may even be another individual, so that when thesubject 100 shake hands both parties are assured of the other'sidentity.

The body associated device 112 comprising the transmission device 603may be a patch, implant, pendant, ring, article of clothing, piercing,or piece of jewelry. The body associated device 112 is physically andelectrically associated with the subject 100, and contains a secret code606.

In one aspect, the authentication receiver module 601 of the targetauthentication device 602 may comprise a transbody conductivecommunication module 402 as described in connection with FIG. 4, shownin phantom to indicate that it is optional. Communication could be overthe same transconductive link established with the ingestible eventmarker system 106 described in FIG. 5, where the transmitter drives adipole located on the body 617 of the subject 100 and the targetauthentication device 602 also contains a dipole for receiving theencoded signal. Alternatively, either the target authentication device602 or the transmission device 603 or both may comprise a singleelectrode in contact with the body 617, with the counter electrode beinga capacitive connection to free space. All of these cases ensure thatboth the transmission device 603 containing the authentication code 606and the target authentication device 602 are both in conductive contactwith the same body 617 in order for authentication to be successful.

In another aspect, the authentication receiver module 601 of the targetauthentication device 602 may comprise a physiological sensing module404 as described in connection with FIG. 4, shown in phantom to indicatethat it is optional. The physiological sensing module 404 may beemployed to monitor biometric signatures associated with the subject 100to establish that it is in fact attached to the subject 100. A profileof physiologic activity, based on parameters like heart rate, activitypatterns, GSR, body temperature, circadian rhythms, and so forth may begenerated on the body-associated device 112. This signature could behashed with the authentication code 606 and transmitted to the targetauthentication device 602. The target authentication device 602 wouldthen compare the biometric signature to a baseline database to confirmthe subject 100. In one aspect, the biometric signature is derived fromthe at least one physiological signal and the biometric signature iscompared to a user-associated signature. The user associated-signaturemay be derived from biometric data stored in a memory over time togenerate a baseline biometric signature, wherein the authenticationmodule device compares the biometric signature to the baseline biometricsignature to authenticate the identity of the user. The user-associatedbiometric signature also may be derived from other sources outside thissystem.

In another aspect, the target authentication device 602 acquires abiometric profile over time and compares past readings against currentones. In this way, a sudden change could indicate that thebody-associated device 112 has been removed from one person and put onanother.

The secret authentication code 606 may be a simple password basedauthentication, in which case the password may be programmed into thetransmission device 603, or the secret authentication code 606 may be amore complex challenge-response scheme where bi-directionalcommunication is used to establish authentication over a public channel.Other established authentication schemes known in the art are alsoapplicable to this case.

In yet another aspect, is to put a lock on the body-associated device112 of some kind. A PIN code or tap pattern could be required to unlockthe body-associated device 112 and enable it to broadcast the keytransconductively (e.g., use the body 617 of the subject 100 as aconductive medium to conduct a current).

The above is a specific instantiation of a key (in this case thebody-associated device 112) communicating with and unlocking a lock (inthis case the target authentication device 602, such as a mobile device102, for example) via transconductive communication. In various otheraspects, this may be generalized to a number of keys (e.g., patch,watch, key fob in pocket, smart shoes, jewelry, clothing, etc.)communicating with any number of locks (e.g., phone, computer, door,car, cash register, ATM, vending machine). In certain instances it maybe beneficial for the communication to be two-way. For instance, in thecase of a body-associated device 112 and a mobile device 102, thebody-associated device 112 initiates a session by periodicallybroadcasting the authentication code 606. The mobile device 102 receivesthe code 606, verifies its authenticity and unlocks the mobile device102 display 204 (FIGS. 2, 3). The mobile phone 102 may then send anacknowledgement back to the body-associated device 112 viatransconduction or a wireless link, and the body-associated device 112might then decide to download stored physiological data to the mobiledevice 102. In another instance, the body-associated device 112 may bepre-programmed for a limited number of authentications; after each timea pairing is established between the body-associated device 112 and themobile device 102, a counter may be incremented until it reaches a limitand the body-associated device 112 is de-authorized.

In another aspect, the relationship between the target identificationdevice 602 and the transmission device 603 can be broadened beyondsecurity and use-related permissions to include assurance of use-relatedbenefits and transactions. For example, in a loyalty management programrelated to the transmission device 603 (which in addition to the itemslisted above could include consumer-related product packaging such asdrink containers), assured use by a specific individual could beconfirmed by the transmission device 603, thereby allowing the loyaltyor other benefits to be granted.

In another aspect, instead of being a personally associatedauthentication token, the transmission device 603 could serve as a valuetoken, like a gift card or event pass. In this case, a temporarytransmission device 603 like an adhesive sticker is sold in aconventional transaction. The buyer applies the adhesive sticker to hisor her body 617, and the value is transferred to a mobile device 102(FIGS. 1-3) upon contact with the body 617 of the subject 100. Inanother example, a club might apply a door key patch to customers thatcannot be removed without rendering it inoperative to control access forthe duration of an event.

In another aspect, the authentication process may be bidirectional inthat the target authentication device 602 (e.g., the mobile device 102)can send a code through the body 617 of the subject 100 to thebody-associated device 112 (e.g., a patch). The body-associated device112 authenticates and sends a signal back to the target authenticationdevice 602 which would then unlock. In another aspect, an electricalcurrent signal from the ingestible event indicator system 106 may besourced by a small implantable device, e.g., dog tag sized, that sends asignal that is collected by the target authentication device 602 forauthentication. The implantable device also may be configured with aphysiological sensing module 404 to collect other physiologicalinformation.

With reference now to FIGS. 1-6, in yet another aspect, a mobile device102 could be modified to receive the transconduction signals produced bythe ingestible event marker system 106 when the owner simply touches themobile device 102. The transconduction signal carries authenticationinformation that identifies the subject 100 touching the mobile device102 as the rightful owner. This eliminates the need to manually enter aPIN, while still assuring that the rightful owner is the subject 100accessing the target authentication device 102.

In one aspect, the source of the transconduction signal could be aningested ingestible event marker system 106 or other transconductionsignal transmission source, such as a body-associated device 112 orsimilar transmission device 603 in direct contact with the body 617 ofthe subject 100. This includes transmitters implanted in the body 617 ofthe subject 100.

FIG. 7 illustrates one aspect of an authentication system 700 comprisinga target authentication device 602 and an authentication transmissionmodule comprising an implantable body-associated device 113 that islocated below the skin of the subject 100. The implantablebody-associated device 113 is similar in functionality to thebody-associated device 112 described in connection with FIG. 6, with theexception that the implantable body-associated device 113 is shown inphantom to indicate that it is implanted below the skin of the subject100.

FIG. 8 illustrates one aspect of an authentication system 800 comprisinga target authentication device 602 and an authentication transmissionmodule comprising and an event marker system 805. The targetauthentication device 602 comprises an authentication receiver module601. The event marker system 805 is located on the on or under the skinof the subject 100 and generates transbody conductive signalsrepresentative of an authentication code. The event marker system 805comprises a transmission device 803.

The event marker system 805 is located on the surface of the skin and iselectrically coupled to the subject 100 via electrodes 604 a, 604 b. Inone aspect, the event marker system 805 comprises a transmission device803 that is configured, or programmed, with a secret code 806 that isstored in memory 808, such as a password or a private key for moresophisticated authentication mechanisms. The event marker system 805acts in broadcast mode. The secret code 806 is read from the memory 808and is encoded into a signal 810 by an encoder 812. The encoded signal810 is converted to an electrically conductive signal 814 by the I/Ointerface circuit 816. The encoded electrically conductive signal 814 isapplied to the body 617 of the subject 100 via the electrodes 604 a, 604b.

In various aspects, the event marker system 805 may include a powersource, such as a power source made up of a pair of electrodesfabricated from dissimilar materials. The event marker system 805 maygenerate electrical power when it comes into contact with fluidsexcreted by the skin. Otherwise, the event marker system 805 isfunctionally equivalent to the operation of the ingestible event marker106 discussed in connection with FIG. 5. It will be appreciated,however, that in certain circumstances a small battery may be providedin the event marker system 805. The event marker system 805 also mayinclude a second power source electrically coupled to the non-conductivecommunication module, such as a coil, e.g., an RFID coil.

The electrically conductive signal 814 is conducted through the body 617of the subject 100 to the authentication receiver module 601 of thetarget authentication device 602. Electrodes 618 a, 618 b detect theelectrically conductive signal 814 from the body 617 and are coupled toa decoder 619 though an I/O interface circuit 620. The decoder 619decodes the electrically conductive signal 814. The decoded code 622 isthen compared by compare module 624 to established criteria 626. Whenthe code 622 matches the established criteria 626, compare module 624signals the processor 628, which determines whether the electricalsignal matches the predetermined criteria to authenticate the identityof the user based on the an electrical signal. If a match occurs, theprocessor 629 unlocks the target authentication device 602 and enablesaccess by the subject 100.

In some embodiments of interest, a non-conductive communication modulemay be provided, which is a wireless radio-frequency module. While thewireless radio-frequency communication module may vary, in someinstances this module is a radio-frequency identification (RFID) module.For ease of description purposes only, embodiments of the invention willnow be further described in terms of embodiments where thenon-conductive communication module is an RFID communication module.However, as noted above the non-conductive communication module may varywidely.

In some instances, the RFID module incorporates, for example, anintegrated circuit and an RF antenna. The RFID module may becommunicatively associated with a conductive module incorporating, forexample, an integrated circuit and a conductive antenna. Either of theRFID module or the conductive module, or both, may function inconjunction with medication and/or medication packaging to receive,process, store, and/or transmit information related to or associatedwith the medication. As indicated above, the devices and systems can beused across multiple and varied applications to provide secure,controlled, and accurate communications in viable, cost-effectiveimplementations.

Although the present disclosure has been described in connection with amobile phone, the application may be broadly extended to include otherinstances where a person needs to authenticate to a system, including,for example access through a locked door, access through a turnstile toget on the subway or into an entertainment venue, access to a computer,access to an ATM or payment terminal at a retailer, access to any othertarget authentication device 602 described herein.

In one aspect, the authentication receiver module is located inside ofan extension chamber on the back of a mobile phone 102 housing 202 (FIG.2). The electrode connections on the module are wired directly to twoelectrodes 618 a, 618 b in the form of metal buttons exposed on the backof the mobile phone housing 202. When the user touches the electrodes618 a, 618 b with fingers from the left and right hand, the transbodyconductive communication module 402 detects transconduction signals froman ingestable event marker system 106 or from a similar signal generatedby an electronic pill emulator. In one aspect, the transbody conductivecommunication module 402 communicates to the target authenticationdevice 602 via a short range wireless connection, such as Bluetooth, forexample. A software module running on the target authentication device602 monitors detection data delivered from the transbody conductivecommunication module 402 and flips its display from Locked to Authorizedto show that the transconduction signal has been received. In anauthentication system, the payload sent in the transconduction signal isconfigured to be secure and personal to the owner. The receiver ishard-wired directly into the electronics of the target authenticationdevice 602, eliminating the Bluetooth link between receiver and phone.

With reference to FIG. 9, there is shown one aspect of an ingestibledevice event indicator system with dissimilar metals positioned onopposite ends as system 2030. The system 2030 can be used in associationwith any pharmaceutical product, as mentioned above, to determine when apatient takes the pharmaceutical product. As indicated above, the scopeof the present invention is not limited by the environment and theproduct that is used with the system 2030. For example, the system 2030may be placed within a capsule and the capsule is placed within theconducting liquid. The capsule would then dissolve over a period of timeand release the system 2030 into the conducting liquid. Thus, in oneaspect, the capsule would contain the system 2030 and no product. Such acapsule may then be used in any environment where a conducting liquid ispresent and with any product. For example, the capsule may be droppedinto a container filled with jet fuel, salt water, tomato sauce, motoroil, or any similar product. Additionally, the capsule containing thesystem 2030 may be ingested at the same time that any pharmaceuticalproduct is ingested in order to record the occurrence of the event, suchas when the product was taken.

In the specific example of the system 2030 combined with thepharmaceutical product, as the product or pill is ingested, the system2030 is activated. The system 2030 controls conductance to produce aunique current signature that is detected, thereby signifying that thepharmaceutical product has been taken. The system 2030 includes aframework 2032. The framework 2032 is a chassis for the system 2030 andmultiple components are attached to, deposited upon, or secured to theframework 2032. In this aspect of the system 2030, a digestible material2034 is physically associated with the framework 2032. The material 2034may be chemically deposited on, evaporated onto, secured to, or built-upon the framework all of which may be referred to herein as “deposit”with respect to the framework 2032. The material 2034 is deposited onone side of the framework 2032. The materials of interest that can beused as material 2034 include, but are not limited to: Cu or CuI. Thematerial 2034 is deposited by physical vapor deposition,electrodeposition, or plasma deposition, among other protocols. Thematerial 2034 may be from about 0.05 to about 500 .mu.m thick, such asfrom about 5 to about 100 .mu.m thick. The shape is controlled by shadowmask deposition, or photolithography and etching. Additionally, eventhough only one region is shown for depositing the material, each system2030 may contain two or more electrically unique regions where thematerial 2034 may be deposited, as desired.

At a different side, which is the opposite side as shown in FIG. 9,another digestible material 2036 is deposited, such that materials 2034and 2036 are dissimilar. Although not shown, the different side selectedmay be the side next to the side selected for the material 2034. Thescope of the present invention is not limited by the side selected andthe term “different side” can mean any of the multiple sides that aredifferent from the first selected side. Furthermore, even though theshape of the system is shown as a square, the shape maybe anygeometrically suitable shape. Material 2034 and 2036 are selected suchthat they produce a voltage potential difference when the system 2030 isin contact with conducting liquid, such as body fluids. The materials ofinterest for material 2036 include, but are not limited to: Mg, Zn, orother electronegative metals. As indicated above with respect to thematerial 2034, the material 2036 may be chemically deposited on,evaporated onto, secured to, or built-up on the framework. Also, anadhesion layer may be necessary to help the material 2036 (as well asmaterial 2034 when needed) to adhere to the framework 2032. Typicaladhesion layers for the material 2036 are Ti, TiW, Cr or similarmaterial. Anode material and the adhesion layer may be deposited byphysical vapor deposition, electrodeposition or plasma deposition. Thematerial 2036 may be from about 0.05 to about 500 .mu.m thick, such asfrom about 5 to about 100 .mu.m thick. However, the scope of the presentinvention is not limited by the thickness of any of the materials nor bythe type of process used to deposit or secure the materials to theframework 2032.

Thus, when the system 2030 is in contact with the conducting liquid, acurrent path, an example is shown in FIG. 11, is formed through theconducting liquid between material 2034 and 2036. A control device 2038is secured to the framework 2032 and electrically coupled to thematerials 2034 and 2036. The control device 2038 includes electroniccircuitry, for example control logic that is capable of controlling andaltering the conductance between the materials 2034 and 2036.

The voltage potential created between the materials 2034 and 2036provides the power for operating the system as well as produces thecurrent flow through the conducting fluid and the system. In one aspect,the system operates in direct current mode. In an alternative aspect,the system controls the direction of the current so that the directionof current is reversed in a cyclic manner, similar to alternatingcurrent. As the system reaches the conducting fluid or the electrolyte,where the fluid or electrolyte component is provided by a physiologicalfluid, e.g., stomach acid, the path for current flow between thematerials 2034 and 2036 is completed external to the system 2030; thecurrent path through the system 2030 is controlled by the control device2038. Completion of the current path allows for the current to flow andin turn a receiver, not shown, can detect the presence of the currentand recognize that the system 2030 has been activate and the desiredevent is occurring or has occurred.

In one aspect, the two materials 2034 and 2036 are similar in functionto the two electrodes needed for a direct current power source, such asa battery. The conducting liquid acts as the electrolyte needed tocomplete the power source. The completed power source described isdefined by the physical chemical reaction between the materials 2034 and2036 of the system 2030 and the surrounding fluids of the body. Thecompleted power source may be viewed as a power source that exploitsreverse electrolysis in an ionic or a conductive solution such asgastric fluid, blood, or other bodily fluids and some tissues.Additionally, the environment may be something other than a body and theliquid may be any conducting liquid. For example, the conducting fluidmay be salt water or a metallic based paint.

In certain aspects, these two materials are shielded from thesurrounding environment by an additional layer of material. Accordingly,when the shield is dissolved and the two dissimilar materials areexposed to the target site, a voltage potential is generated.

Referring again to FIG. 9, the materials 2034 and 2036 provide thevoltage potential to activate the control device 2038. Once the controldevice 2038 is activated or powered up, the control device 2038 canalter conductance between the materials 2034 and 2036 in a uniquemanner. By altering the conductance between materials 2034 and 2036, thecontrol device 2038 is capable of controlling the magnitude of thecurrent through the conducting liquid that surrounds the system 2030.This produces a unique current signature that can be detected andmeasured by a receiver (not shown), which can be positioned internal orexternal to the body. In addition to controlling the magnitude of thecurrent path between the materials, non-conducting materials, membrane,or “skirt” are used to increase the “length” of the current path and,hence, act to boost the conductance path, as disclosed in the U.S.patent application Ser. No. 12/238,345 entitled, “In-Body Device withVirtual Dipole Signal Amplification” filed Sep. 25, 2008, the entirecontent of which is incorporated herein by reference. Alternatively,throughout the disclosure herein, the terms “non-conducting material”,“membrane”, and “skirt” are interchangeably with the term “current pathextender” without impacting the scope or the present aspects and theclaims herein. The skirt, shown in portion at 2035 and 2037,respectively, may be associated with, e.g., secured to, the framework2032. Various shapes and configurations for the skirt are contemplatedas within the scope of the present invention. For example, the system2030 may be surrounded entirely or partially by the skirt and the skirtmaybe positioned along a central axis of the system 2030 or off-centerrelative to a central axis. Thus, the scope of the present invention asclaimed herein is not limited by the shape or size of the skirt.Furthermore, in other aspects, the materials 2034 and 2036 may beseparated by one skirt that is positioned in any defined region betweenthe materials 2034 and 2036.

Referring now to FIG. 10, in another aspect of an ingestible device isshown in more detail as system 2040. The system 2040 includes aframework 2042. The framework 2042 is similar to the framework 2032 ofFIG. 9. In this aspect of the system 2040, a digestible or dissolvablematerial 2044 is deposited on a portion of one side of the framework2042. At a different portion of the same side of the framework 2042,another digestible material 2046 is deposited, such that materials 2044and 2046 are dissimilar. More specifically, material 2044 and 2046 areselected such that they form a voltage potential difference when incontact with a conducting liquid, such as body fluids. Thus, when thesystem 2040 is in contact with and/or partially in contact with theconducting liquid, then a current path, an example is shown in FIG. 11,is formed through the conducting liquid between material 2044 and 2046.A control device 2048 is secured to the framework 2042 and electricallycoupled to the materials 2044 and 2046. The control device 2048 includeselectronic circuitry that is capable of controlling part of theconductance path between the materials 2044 and 2046. The materials 2044and 2046 are separated by a non-conducting skirt 2049. Various examplesof the skirt 2049 are disclosed in U.S. Provisional Application No.61/173,511 filed on Apr. 28, 2009 and entitled “HIGHLY RELIABLEINGESTIBLE EVENT MARKERS AND METHODS OF USING SAME” and U.S. ProvisionalApplication No. 61/173,564 filed on Apr. 28, 2009 and entitled“INGESTIBLE EVENT MARKERS HAVING SIGNAL AMPLIFIERS THAT COMPRISE ANACTIVE AGENT”; as well as U.S. application Ser. No. 12/238,345 filedSep. 25, 2008 and published as 2009-0082645, entitled “IN-BODY DEVICEWITH VIRTUAL DIPOLE SIGNAL AMPLIFICATION”; the entire disclosure of eachis incorporated herein by reference.

Once the control device 2048 is activated or powered up, the controldevice 2048 can alter conductance between the materials 2044 and 2046.Thus, the control device 2048 is capable of controlling the magnitude ofthe current through the conducting liquid that surrounds the system2040. As indicated above with respect to system 2030, a unique currentsignature that is associated with the system 2040 can be detected by areceiver (not shown) to mark the activation of the system 2040. In orderto increase the “length” of the current path the size of the skirt 2049is altered. The longer the current path, the easier it may be for thereceiver to detect the current.

Referring now to FIG. 11, the system 2030 of FIG. 9 is shown in anactivated state and in contact with conducting liquid. The system 2030is grounded through ground contact 2052. The system 2030 also includes asensor module 2074, which is described in greater detail with respect toFIG. 11 Ion or current paths 2050 form between material 2034 to material2036 through the conducting fluid in contact with the system 2030. Thevoltage potential created between the material 2034 and 2036 is createdthrough chemical reactions between materials 2034/2036 and theconducting fluid.

FIG. 11A shows an exploded view of the surface of the material 2034. Thesurface of the material 2034 is not planar, but rather an irregularsurface 2054 as shown. The irregular surface 2054 increases the surfacearea of the material and, hence, the area that comes in contact with theconducting fluid.

In one aspect, at the surface of the material 2034, there is chemicalreaction between the material 2034 and the surrounding conducting fluidsuch that mass is released into the conducting fluid. The term “mass” asused herein refers to protons and neutrons that form a substance. Oneexample includes the instant where the material is CuCl and when incontact with the conducting fluid, CuCl becomes Cu (solid) andCl.sup.-in solution. The flow of ions into the conduction fluid isdepicted by the ion paths 2050. In a similar manner, there is a chemicalreaction between the material 2036 and the surrounding conducting fluidand ions are captured by the material 2036. The release of ions at thematerial 2034 and capture of ion by the material 2036 is collectivelyreferred to as the ionic exchange. The rate of ionic exchange and, hencethe ionic emission rate or flow, is controlled by the control device2038. The control device 2038 can increase or decrease the rate of ionflow by altering the conductance, which alters the impedance, betweenthe materials 2034 and 2036. Through controlling the ion exchange, thesystem 2030 can encode information in the ionic exchange process. Thus,the system 2030 uses ionic emission to encode information in the ionicexchange.

The control device 2038 can vary the duration of a fixed ionic exchangerate or current flow magnitude while keeping the rate or magnitude nearconstant, similar to when the frequency is modulated and the amplitudeis constant. Also, the control device 2038 can vary the level of theionic exchange rate or the magnitude of the current flow while keepingthe duration near constant. Thus, using various combinations of changesin duration and altering the rate or magnitude, the control device 2038encodes information in the current flow or the ionic exchange. Forexample, the control device 2038 may use, but is not limited to any ofthe following techniques namely, Binary Phase-Shift Keying (PSK),Frequency modulation, Amplitude modulation, on-off keying, and PSK withon-off keying.

As indicated above, the various aspects disclosed herein, such assystems 2030 and 2040 of FIGS. 9 and 10, respectively, includeelectronic components as part of the control device 2038 or the controldevice 2048. Components that may be present include but are not limitedto: logic and/or memory elements, an integrated circuit, an inductor, aresistor, and sensors for measuring various parameters. Each componentmay be secured to the framework and/or to another component. Thecomponents on the surface of the support may be laid out in anyconvenient configuration. Where two or more components are present onthe surface of the solid support, interconnects may be provided.

As indicated above, the system, such as system 2030 and 2040, controlthe conductance between the dissimilar materials and, hence, the rate ofionic exchange or the current flow. Through altering the conductance ina specific manner the system is capable of encoding information in theionic exchange and the current signature. The ionic exchange or thecurrent signature is used to uniquely identify the specific system.Additionally, the systems 2030 and 2040 are capable of producing variousdifferent unique exchanges or signatures and, thus, provide additionalinformation. For example, a second current signature based on a secondconductance alteration pattern may be used to provide additionalinformation, which information may be related to the physicalenvironment. To further illustrate, a first current signature may be avery low current state that maintains an oscillator on the chip and asecond current signature may be a current state at least a factor of tenhigher than the current state associated with the first currentsignature.

Referring now to FIG. 12, a block diagram representation of the controldevice 2038 is shown. The device 2030 includes a control module 2062, acounter or clock 2064, and a memory 2066. Additionally, the device 2038is shown to include a sensor module 2072 as well as the sensor module2074, which was referenced in FIG. 11. The control module 2062 has aninput 2068 electrically coupled to the material 2034 and an output 2070electrically coupled to the material 2036. The control module 2062, theclock 2064, the memory 2066, and the sensor modules 2072/2074 also havepower inputs (some not shown). The power for each of these components issupplied by the voltage potential produced by the chemical reactionbetween materials 2034 and 2036 and the conducting fluid, when thesystem 2030 is in contact with the conducting fluid. The control module2062 controls the conductance through logic that alters the overallimpedance of the system 2030. The control module 2062 is electricallycoupled to the clock 2064. The clock 2064 provides a clock cycle to thecontrol module 2062. Based upon the programmed characteristics of thecontrol module 2062, when a set number of clock cycles have passed, thecontrol module 2062 alters the conductance characteristics betweenmaterials 2034 and 2036. This cycle is repeated and thereby the controldevice 2038 produces a unique current signature characteristic. Thecontrol module 2062 is also electrically coupled to the memory 2066.Both the clock 2064 and the memory 2066 are powered by the voltagepotential created between the materials 2034 and 2036.

The control module 2062 is also electrically coupled to and incommunication with the sensor modules 2072 and 2074. In the aspectshown, the sensor module 2072 is part of the control device 2038 and thesensor module 2074 is a separate component. In alternative aspects,either one of the sensor modules 2072 and 2074 can be used without theother and the scope of the present invention is not limited by thestructural or functional location of the sensor modules 2072 or 2074.Additionally, any component of the system 2030 may be functionally orstructurally moved, combined, or repositioned without limiting the scopeof the present invention as claimed. Thus, it is possible to have onesingle structure, for example a processor, which is designed to performthe functions of all of the following modules: the control module 2062,the clock 2064, the memory 2066, and the sensor module 2072 or 2074. Onthe other hand, it is also within the scope of the present invention tohave each of these functional components located in independentstructures that are linked electrically and able to communicate.

Referring again to FIG. 12, the sensor modules 2072 or 2074 can includeany of the following sensors: temperature, pressure, pH level, andconductivity. In one aspect, the sensor modules 2072 or 2074 gatherinformation from the environment and communicate the analog informationto the control module 2062. The control module then converts the analoginformation to digital information and the digital information isencoded in the current flow or the rate of the transfer of mass thatproduces the ionic flow. In another aspect, the sensor modules 2072 or2074 gather information from the environment and convert the analoginformation to digital information and then communicate the digitalinformation to control module 2062. In the aspect shown in FIG. 11, thesensor modules 2074 is shown as being electrically coupled to thematerial 2034 and 2036 as well as the control device 2038. In anotheraspect, as shown in FIG. 12, the sensor module 2074 is electricallycoupled to the control device 2038 at connection 2078. The connection2078 acts as both a source for power supply to the sensor module 2074and a communication channel between the sensor module 2074 and thecontrol device 2038.

Referring now to FIG. 11B, the system 2030 includes a pH sensor module2076 connected to a material 2039, which is selected in accordance withthe specific type of sensing function being performed. The pH sensormodule 2076 is also connected to the control device 2038. The material2039 is electrically isolated from the material 2034 by a non-conductivebarrier 2055. In one aspect, the material 2039 is platinum. Inoperation, the pH sensor module 2076 uses the voltage potentialdifference between the materials 2034/2036. The pH sensor module 2076measures the voltage potential difference between the material 2034 andthe material 2039 and records that value for later comparison. The pHsensor module 2076 also measures the voltage potential differencebetween the material 2039 and the material 2036 and records that valuefor later comparison. The pH sensor module 2076 calculates the pH levelof the surrounding environment using the voltage potential values. ThepH sensor module 2076 provides that information to the control device2038. The control device 2038 varies the rate of the transfer of massthat produces the ionic transfer and the current flow to encode theinformation relevant to the pH level in the ionic transfer, which can bedetected by a receiver (not shown). Thus, the system 2030 can determineand provide the information related to the pH level to a source externalto the environment.

As indicated above, the control device 2038 can be programmed in advanceto output a pre-defined current signature. In another aspect, the systemcan include a receiver system that can receive programming informationwhen the system is activated. In another aspect, not shown, the switch2064 and the memory 2066 can be combined into one device.

In addition to the above components, the system 2030 may also includeone or other electronic components. Electrical components of interestinclude, but are not limited to: additional logic and/or memoryelements, e.g., in the form of an integrated circuit; a power regulationdevice, e.g., battery, fuel cell or capacitor; a sensor, a stimulator,etc.; a signal transmission element, e.g., in the form of an antenna,electrode, coil, etc.; a passive element, e.g., an inductor, resistor,etc.

FIG. 13 provides a functional block diagram of how a receiver mayimplement a coherent demodulation protocol, according to one aspect ofthe invention. It should be noted that only a portion of the receiver isshown in FIG. 13. FIG. 13 illustrates the process of mixing the signaldown to baseband once the carrier frequency (and carrier signal mixeddown to carrier offset) is determined. A carrier signal 2221 is mixedwith a second carrier signal 2222 at mixer 2223. A narrow low-passfilter 2220 is applied of appropriate bandwidth to reduce the effect ofout-of-bound noise. Demodulation occurs at functional blocks 2225 inaccordance with the coherent demodulation scheme of the presentinvention. The unwrapped phase 2230 of the complex signal is determined.An optional third mixer stage, in which the phase evolution is used toestimate the frequency differential between the calculated and realcarrier frequency can be applied. The structure of the packet is thenleveraged to determine the beginning of the coding region of the BPSKsignal at block 2240. Mainly, the presence of the sync header, whichappears as an FM porch in the amplitude signal of the complexdemodulated signal is used to determine the starting bounds of thepacket. Once the starting point of the packet is determined the signalis rotated at block 2250 on the IQ plane and standard bit identificationand eventually decoded at block 2260.

In addition to demodulation, the transbody communication module mayinclude a forward error correction module, which module providesadditional gain to combat interference from other unwanted signals andnoise. Forward error correction functional modules of interest includethose described in PCT Application Serial No. PCT/US2007/024225; thedisclosure of which is herein incorporated by reference. In someinstances, the forward error correction module may employ any convenientprotocol, such as Reed-Solomon, Golay, Hamming, BCH, and Turbo protocolsto identify and correct (within bounds) decoding errors.

Receivers of the invention may further employ a beacon functionalitymodule. In various aspects, the beacon switching module may employ oneor more of the following: a beacon wakeup module, a beacon signalmodule, a wave/frequency module, a multiple frequency module, and amodulated signal module.

The beacon switching module may be associated with beaconcommunications, e.g., a beacon communication channel, a beacon protocol,etc. For the purpose of the present disclosure, beacons are typicallysignals sent either as part of a message or to augment a message(sometimes referred to herein as “beacon signals”). The beacons may havewell-defined characteristics, such as frequency. Beacons may be detectedreadily in noisy environments and may be used for a trigger to a sniffcircuit, such as described below. In one aspect, the beacon switchingmodule may comprise the beacon wakeup module, having wakeupfunctionality. Wakeup functionality generally comprises thefunctionality to operate in high power modes only during specific times,e.g., short periods for specific purposes, to receive a signal, etc. Animportant consideration on a receiver portion of a system is that it beof low power. This feature may be advantageous in an implanted receiver,to provide for both small size and to preserve a long-functioningelectrical supply from a battery. The beacon switching module enablesthese advantages by having the receiver operate in a high power mode forvery limited periods of time. Short duty cycles of this kind can provideoptimal system size and energy draw features.

In practice, the receiver may “wake up” periodically, and at low energyconsumption, to perform a “sniff function” via, for example, a sniffcircuit. For the purpose of the present application, the term “snifffunction” generally refers to a short, low-power function to determineif a transmitter is present. If a transmitter signal is detected by thesniff function, the device may transition to a higher powercommunication decode mode. If a transmitter signal is not present, thereceiver may return, e.g., immediately return, to sleep mode. In thismanner, energy is conserved during relatively long periods when atransmitter signal is not present, while high-power capabilities remainavailable for efficient decode mode operations during the relatively fewperiods when a transmit signal is present. Several modes, andcombination thereof, may be available for operating the sniff circuit.By matching the needs of a particular system to the sniff circuitconfiguration, an optimized system may be achieved.

Another view of a beacon module is provided in the functional blockdiagram shown in FIG. 14. The scheme outlined in FIG. 14 outlines onetechnique for identifying a valid beacon. The incoming signal 2360represents the signals received by electrodes, bandpass filtered (suchas from 10 KHz to 34 KHz) by a high frequency signaling chain (whichencompasses the carrier frequency), and converted from analog todigital. The signal 2360 is then decimated at block 2361 and mixed atthe nominal drive frequency (such as, 12.5 KHz, 20 KHz, etc.) at mixer2362. The resulting signal is decimated at block 2364 and low-passfiltered (such as 5 KHz BW) at block 2365 to produce the carrier signalmixed down to carrier offset—signal 2369. Signal 2369 is furtherprocessed by blocks 2367 (fast Fourier transform and then detection oftwo strongest peaks) to provide the true carrier frequency signal 2368.This protocol allows for accurate determination of the carrier frequencyof the transmitted beacon.

FIG. 15 provides a block functional diagram of an integrated circuitcomponent of a signal receiver according to an aspect of the invention.In FIG. 15, receiver 2700 includes electrode input 2710. Electricallycoupled to the electrode input 2710 are transbody conductivecommunication module 2720 and physiological sensing module 2730. In oneaspect, transbody conductive communication module 2720 is implemented asa high frequency (HF) signal chain and physiological sensing module 2730is implemented as a low frequency (LF) signal chain. Also shown are CMOStemperature sensing module 2740 (for detecting ambient temperature) anda 3-axis accelerometer 2750. Receiver 2700 also includes a processingengine 2760 (for example, a microcontroller and digital signalprocessor), non-volatile memory 2770 (for data storage) and wirelesscommunication module 2780 (for data transmission to another device, forexample in a data upload action).

FIG. 16 provides a more detailed block diagram of a circuit configuredto implement the block functional diagram of the receiver depicted inFIG. 15, according to one aspect of the invention. In FIG. 16, receiver800 includes electrodes e1, e2 and e3 (2811, 2812 and 2813) which, forexample, receive the conductively transmitted signals by an IEM and/orsense physiological parameters or biomarkers of interest. The signalsreceived by the electrodes 2811, 2812, and 2813 are multiplexed bymultiplexer 820 which is electrically coupled to the electrodes.

Multiplexer 2820 is electrically coupled to both high band pass filter2830 and low band pass filter 2840. The high and low frequency signalchains provide for programmable gain to cover the desired level orrange. In this specific aspect, high band pass filter 2830 passesfrequencies in the 10 KHz to 34 KHz band while filtering out noise fromout-of-band frequencies. This high frequency band may vary, and mayinclude, for example, a range of 3 KHz to 300 KHz. The passingfrequencies are then amplified by amplifier 2832 before being convertedinto a digital signal by converter 2834 for input into high powerprocessor 2880 (shown as a DSP) which is electrically coupled to thehigh frequency signal chain.

Low band pass filter 2840 is shown passing lower frequencies in therange of 0.5 Hz to 150 Hz while filtering out out-of-band frequencies.The frequency band may vary, and may include, for example, frequenciesless than 300 Hz, such as less than 200 Hz, including less than 150 Hz.The passing frequency signals are amplified by amplifier 842. Also shownis accelerometer 850 electrically coupled to second multiplexer 2860.Multiplexer 2860 multiplexes the signals from the accelerometer with theamplified signals from amplifier 2842. The multiplexed signals are thenconverted to digital signals by converter 864 which is also electricallycoupled to low power processor 2870.

In one aspect, a digital accelerometer (such as one manufactured byAnalog Devices), may be implemented in place of accelerometer 2850.Various advantages may be achieved by using a digital accelerometer. Forexample, because the signals the digital accelerometer would producesignals already in digital format, the digital accelerometer couldbypass converter 2864 and electrically couple to the low powermicrocontroller 2870—in which case multiplexer 2860 would no longer berequired. Also, the digital signal may be configured to turn itself onwhen detecting motion, further conserving power. In addition, continuousstep counting may be implemented. The digital accelerometer may includea FIFO buffer to help control the flow of data sent to the low powerprocessor 2870. For instance, data may be buffered in the FIFO untilfull, at which time the processor may be triggered to turn awaken froman idle state and receive the data.

Low power processor 2870 may be, for example, an MSP430 microcontrollerfrom Texas Instruments. Low power processor 2870 of receiver 2800maintains the idle state, which as stated earlier, requires minimalcurrent draw—e.g., 10 μA or less, or 1 μA or less.

High power processor 2880 may be, for example, a VC5509 digital signalprocess from Texas Instruments. The high power processor 2880 performsthe signal processing actions during the active state. These actions, asstated earlier, require larger amounts of current than the idlestate—e.g., currents of 30 μA or more, such as 50 μA or more—and mayinclude, for example, actions such as scanning for conductivelytransmitted signals, processing conductively transmitted signals whenreceived, obtaining and/or processing physiological data, etc.

The receiver may include a hardware accelerator module to process datasignals. The hardware accelerator module may be implemented instead of,for example, a DSP. Being a more specialized computation unit, itperforms aspects of the signal processing algorithm with fewertransistors (less cost and power) compared to the more general purposeDSP. The blocks of hardware may be used to “accelerate” the performanceof important specific function(s). Some architectures for hardwareaccelerators may be “programmable” via microcode or VLIW assembly. Inthe course of use, their functions may be accessed by calls to functionlibraries.

The hardware accelerator (HWA) module comprises an HWA input block toreceive an input signal that is to be processed and instructions forprocessing the input signal; and, an HWA processing block to process theinput signal according to the received instructions and to generate aresulting output signal. The resulting output signal may be transmittedas needed by an HWA output block.

Also shown in FIG. 16 is flash memory 2890 electrically coupled to highpower processor 2880. In one aspect, flash memory 2890 may beelectrically coupled to low power processor 2870, which may provide forbetter power efficiency.

Wireless communication element 2895 is shown electrically coupled tohigh power processor 2880 and may include, for example, a BLUETOOTH™wireless communication transceiver. In one aspect, wirelesscommunication element 2895 is electrically coupled to high powerprocessor 2880. In another aspect, wireless communication element 2895is electrically coupled to high power processor 2880 and low powerprocessor 2870. Furthermore, wireless communication element 2895 may beimplemented to have its own power supply so that it may be turned on andoff independently from other components of the receiver—e.g., by amicroprocessor.

FIG. 17 provides a view of a block diagram of hardware in a receiveraccording to an aspect of the invention related to the high frequencysignal chain. In FIG. 17, receiver 2900 includes receiver probes (forexample in the form of electrodes 2911, 2912 and 2913) electricallycoupled to multiplexer 2920. Also shown are high pass filter 2930 andlow pass filter 2940 to provide for a band pass filter which eliminatesany out-of-band frequencies. In the aspect shown, a band pass of 10 KHzto 34 KHz is provided to pass carrier signals falling within thefrequency band. Example carrier frequencies may include, but are notlimited to, 12.5 KHz and 20 KHz. One or more carriers may be present. Inaddition, receiver 2900 includes analog to digital converter 2950—forexample, sampling at 500 KHz. The digital signal can thereafter beprocessed by the DSP. Shown in this aspect is DMA to DSP unit 960 whichsends the digital signal to dedicated memory for the DSP. The directmemory access provides the benefit of allowing the rest of the DSP toremain in a low power mode.

Example Configurations for Various States

As stated earlier, for each receiver state, the high power functionalblock may be cycled between active and inactive states accordingly.Also, for each receiver state, various receiver elements (such ascircuit blocks, power domains within processor, etc.) of a receiver maybe configured to independently cycle from on and off by the power supplymodule. Therefore, the receiver may have different configurations foreach state to achieve power efficiency.

In certain aspects, the receivers are part of a body-associated systemor network of devices, such as sensors, signal receivers, and optionallyother devices, which may be internal and/or external, which provide avariety of different types of information that is ultimately collectedand processed by a processor, such as an external processor, which thencan provide contextual data about a living subject, such as a patient,as output. For example, the receiver may be a member of an in-bodynetwork of devices which can provide an output that includes data aboutIEM ingestion, one or more physiological sensed parameters, implantabledevice operation, etc., to an external collector of the data. Theexternal collector, e.g., in the form of a health care network server,etc., of the data then combines this receiver provided data withadditional relevant data about the patient, e.g., weight, weather,medical record data, etc., and may process this disparate data toprovide highly specific and contextual patient specific data.

Systems of the invention include, in certain aspects, a signal receiveraspect of a receiver and one or more IEMs. IEMs of interest includethose described in PCT application serial no. PCT/US2006/016370published as WO/2006/116718; PCT application serial no.PCT/US2007/082563 published as WO/2008/052136; PCT application serialno. PCT/US2007/024225 published as WO/2008/063626; PCT applicationserial no. PCT/US2007/022257 published as WO/2008/066617; PCTapplication serial no. PCT/US2008/052845 published as WO/2008/095183;PCT application serial no. PCT/US2008/053999 published asWO/2008/101107; PCT application serial no. PCT/US2008/056296 publishedas WO/2008/112577; PCT application serial no. PCT/US2008/056299published as WO/2008/112578; and PCT application serial no.PCT/US2008/077753 published as WO 2009/042812; the disclosures of whichapplications are herein incorporated by reference.

In certain aspects the systems include an external device which isdistinct from the receiver (which may be implanted or topically appliedin certain aspects), where this external device provides a number offunctionalities. Such an external device can include the capacity toprovide feedback and appropriate clinical regulation to the patient.Such a device can take any of a number of forms. For example, the devicecan be configured to sit on the bed next to the patient, e.g., a bedsidemonitor. Other formats include, but are not limited to, PDAs, smartphones, home computers, etc.

An example of a system of the invention is shown in FIG. 18A. In FIG.18A, system 1500 includes a pharmaceutical composition 1510 thatcomprises an IEM. Also present in system 1500 is signal receiver 1520,such as the signal receiver illustrated in FIGS. 10 to 12. Signalreceiver 1520 is configured to detect a signal emitted from theidentifier of the IEM 1510. Signal receiver 1520 also includesphysiologic sensing capability, such as ECG and movement sensingcapability. Signal receiver 1520 is configured to transmit data to apatient's an external device or PDA 1530 (such as a smart phone or otherwireless communication enabled device), which in turn transmits the datato a server 1540. Server 1540 may be configured as desired, e.g., toprovide for patient directed permissions. For example, server 1540 maybe configured to allow a family caregiver 1550 to participate in thepatient's therapeutic regimen, e.g., via an interface (such as a webinterface) that allows the family caregiver 1550 to monitor alerts andtrends generated by the server 1540, and provide support back to thepatient, as indicated by arrow 1560. The server 1540 may also beconfigured to provide responses directly to the patient, e.g., in theform of patient alerts, patient incentives, etc., as indicated by arrow1565 which are relayed to the patient via PDA 1530. Server 1540 may alsointeract with a health care professional (e.g., RN, physician) 1555,which can use data processing algorithms to obtain measures of patienthealth and compliance, e.g., wellness index summaries, alerts,cross-patient benchmarks, etc., and provide informed clinicalcommunication and support back to the patient, as indicated by arrow1580.

Another example of the system of the present invention is shown in FIG.18B. FIG. 18B depicts a system that includes a syringe 15107, a receiver15105, a glucometer 15110, a wireless communication unit 15115,communication links 15150B-E, and a dosage manager 15160. The systemgenerally provides intelligent mechanisms for controlling the deliveryof a dosage by the syringe 15107 (e.g., subcutaneous needle insertion orluer connection with an Intra Venous access device). This control mayinclude, for example, detecting that the syringe 15107 is proximate tothe patient, measuring the amount of the dose administered by thesyringe 15107, communicating the measurement information to otherdevices, such as the receiver 15105, the glucometer 15110, the wirelessdevices 15115, and/or the dosage manager 15160, and providing feedbackinformation to one or more of those devices. In some implementations,the feedback information may prevent the administration of the dosage tothe patient using, for example, an interlock at the syringe 15107 toprevent giving the dosage. The syringe 15107 may, based on the feedback,output a visual indication (e.g., a light emitting diode (LED)) or anaural signal to indicate that the dosage is not to be administered tothe patient. For example, the interlock mechanism, LED, and/or sound atthe syringe 15107 may signal that the patient is receiving the wrongtype of medication, receiving the dosage at the wrong time, and/orreceiving the wrong amount of medication.

In some implementations, the syringe 15107 may be configured in aninterlock mode as a default state to prevent the administration of adosage until the dosage manager 15160 provides feedback information tounlock the syringe 15107 to allow the administration of the agent ormedication.

Moreover, the syringe 15107 may, in some embodiments, include ameasurement mechanism to provide measurement information representativeof the amount of the dosage. When that is the case, the measurementinformation may be used by the dosage manager 160 along with otherpatient information, such as blood pressure, glucose level, heart rate,ingestible event marker (IEM) data, etc., to control when, and/or howmuch of, a dosage is provided to the patient. Furthermore, the syringe15107 may activate the measurement mechanism (which provides themeasured information) when the syringe 15107 is proximate to (e.g.,enters or is close to) the patient's body, at which time the measurementinformation and other information, such as an identifier associated withthe syringe 15107, a patient identifier, etc, are carried by a signal toother devices, such as the receiver 15105, the glucometer 15110, and/orthe wireless device 15115, for communication to the dosage manager15160. Moreover, these other devices may monitor the time when thedosage is administered by the syringe 15107. As such, the dosage manager15160 may receive a precise time when the dosage is administered ratherthan rely on user-provided dosage administration times. As such, thesystem may be used to evaluate a specific fluid transfer event between aparenteral fluid delivery device, such as syringe 15107, and a patient

While various details have been set forth in the foregoing description,it will be appreciated that the various aspects of the personalauthentication apparatus, system, and method may be practiced withoutthese specific details. For example, for conciseness and clarityselected aspects have been shown in block diagram form rather than indetail. Some portions of the detailed descriptions provided herein maybe presented in terms of instructions that operate on data that isstored in a computer memory. Such descriptions and representations areused by those skilled in the art to describe and convey the substance oftheir work to others skilled in the art. In general, an algorithm refersto a self-consistent sequence of steps leading to a desired result,where a “step” refers to a manipulation of physical quantities whichmay, though need not necessarily, take the form of electrical ormagnetic signals capable of being stored, transferred, combined,compared, and otherwise manipulated. It is common usage to refer tothese signals as bits, values, elements, symbols, characters, terms,numbers, or the like. These and similar terms may be associated with theappropriate physical quantities and are merely convenient labels appliedto these quantities.

Unless specifically stated otherwise as apparent from the foregoingdiscussion, it is appreciated that, throughout the foregoingdescription, discussions using terms such as “processing” or “computing”or “calculating” or “determining” or “displaying” or the like, refer tothe action and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

It is worthy to note that any reference to “one aspect,” “an aspect,”“one embodiment,” or “an embodiment” means that a particular feature,structure, or characteristic described in connection with the aspect isincluded in at least one aspect. Thus, appearances of the phrases “inone aspect,” “in an aspect,” “in one embodiment,” or “in an embodiment”in various places throughout the specification are not necessarily allreferring to the same aspect. Furthermore, the particular features,structures or characteristics may be combined in any suitable manner inone or more aspects.

Some aspects may be described in accordance with the expression“coupled” and “connected” along with their derivatives. It should beunderstood that these terms are not intended as synonyms for each other.For example, some aspects may be described using the term “connected” toindicate that two or more elements are in direct physical or electricalcontact with each other. In another example, some aspects may bedescribed using the term “coupled” to indicate that two or more elementsare in direct physical or electrical contact. The term “coupled,”however, also may mean that two or more elements are not in directcontact with each other, but yet still co-operate or interact with eachother.

It is worthy to note that any reference to “one aspect,” “an aspect,”“one embodiment,” or “an embodiment” means that a particular feature,structure, or characteristic described in connection with the aspect isincluded in at least one aspect. Thus, appearances of the phrases “inone aspect,” “in an aspect,” “in one embodiment,” or “in an embodiment”in various places throughout the specification are not necessarily allreferring to the same aspect. Furthermore, the particular features,structures or characteristics may be combined in any suitable manner inone or more aspects.

Although various embodiments have been described herein, manymodifications, variations, substitutions, changes, and equivalents tothose embodiments may be implemented and will occur to those skilled inthe art. Also, where materials are disclosed for certain components,other materials may be used. It is therefore to be understood that theforegoing description and the appended claims are intended to cover allsuch modifications and variations as falling within the scope of thedisclosed embodiments. The following claims are intended to cover allsuch modification and variations.

In a general sense, those skilled in the art will recognize that thevarious aspects described herein which can be implemented, individuallyand/or collectively, by a wide range of hardware, software, firmware, orany combination thereof can be viewed as being composed of various typesof “electrical circuitry.” Consequently, as used herein “electricalcircuitry” includes, but is not limited to, electrical circuitry havingat least one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes and/or devices described herein,or a microprocessor configured by a computer program which at leastpartially carries out processes and/or devices described herein),electrical circuitry forming a memory device (e.g., forms of randomaccess memory), and/or electrical circuitry forming a communicationsdevice (e.g., a modem, communications switch, or optical-electricalequipment). Those having skill in the art will recognize that thesubject matter described herein may be implemented in an analog ordigital fashion or some combination thereof.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, or examples can be implemented,individually and/or collectively, by a wide range of hardware, software,firmware, or virtually any combination thereof. In one embodiment,several portions of the subject matter described herein may beimplemented via Application Specific Integrated Circuits (ASICs), FieldProgrammable Gate Arrays (FPGAs), digital signal processors (DSPs), orother integrated formats. However, those skilled in the art willrecognize that some aspects of the embodiments disclosed herein, inwhole or in part, can be equivalently implemented in integratedcircuits, as one or more computer programs running on one or morecomputers (e.g., as one or more programs running on one or more computersystems), as one or more programs running on one or more processors(e.g., as one or more programs running on one or more microprocessors),as firmware, or as virtually any combination thereof, and that designingthe circuitry and/or writing the code for the software and or firmwarewould be well within the skill of one of skill in the art in light ofthis disclosure. In addition, those skilled in the art will appreciatethat the mechanisms of the subject matter described herein are capableof being distributed as a program product in a variety of forms, andthat an illustrative embodiment of the subject matter described hereinapplies regardless of the particular type of signal bearing medium usedto actually carry out the distribution. Examples of a signal bearingmedium include, but are not limited to, the following: a recordable typemedium such as a floppy disk, a hard disk drive, a Compact Disc (CD), aDigital Video Disk (DVD), a digital tape, a computer memory, etc.; and atransmission type medium such as a digital and/or an analogcommunication medium (e.g., a fiber optic cable, a waveguide, a wiredcommunications link, a wireless communication link (e.g., transmitter,receiver, transmission logic, reception logic, etc.), etc.).

All of the above-mentioned U.S. patents, U.S. patent applicationpublications, U.S. patent applications, foreign patents, foreign patentapplications, non-patent publications referred to in this specificationand/or listed in any Application Data Sheet, or any other disclosurematerial are incorporated herein by reference, to the extent notinconsistent herewith. As such, and to the extent necessary, thedisclosure as explicitly set forth herein supersedes any conflictingmaterial incorporated herein by reference. Any material, or portionthereof, that is said to be incorporated by reference herein, but whichconflicts with existing definitions, statements, or other disclosurematerial set forth herein will only be incorporated to the extent thatno conflict arises between that incorporated material and the existingdisclosure material.

One skilled in the art will recognize that the herein describedcomponents (e.g., operations), devices, objects, and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are contemplated.Consequently, as used herein, the specific exemplars set forth and theaccompanying discussion are intended to be representative of their moregeneral classes. In general, use of any specific exemplar is intended tobe representative of its class, and the non-inclusion of specificcomponents (e.g., operations), devices, and objects should not be takenlimiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations are not expressly set forth herein for sakeof clarity.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures may beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected,” or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

In some instances, one or more components may be referred to herein as“configured to,” “configurable to,” “operable/operative to,”“adapted/adaptable,” “able to,” “conformable/conformed to,” etc. Thoseskilled in the art will recognize that “configured to” can generallyencompass active-state components and/or inactive-state componentsand/or standby-state components, unless context requires otherwise.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationsmay be made without departing from the subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of the subject matter described herein.It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flows are presented in asequence(s), it should be understood that the various operations may beperformed in other orders than those which are illustrated, or may beperformed concurrently. Examples of such alternate orderings may includeoverlapping, interleaved, interrupted, reordered, incremental,preparatory, supplemental, simultaneous, reverse, or other variantorderings, unless context dictates otherwise. Furthermore, terms like“responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

In certain cases, use of a system or method may occur in a territoryeven if components are located outside the territory. For example, in adistributed computing context, use of a distributed computing system mayoccur in a territory even though parts of the system may be locatedoutside of the territory (e.g., relay, server, processor, signal-bearingmedium, transmitting computer, receiving computer, etc. located outsidethe territory).

A sale of a system or method may likewise occur in a territory even ifcomponents of the system or method are located and/or used outside theterritory. Further, implementation of at least part of a system forperforming a method in one territory does not preclude use of the systemin another territory.

Although various embodiments have been described herein, manymodifications, variations, substitutions, changes, and equivalents tothose embodiments may be implemented and will occur to those skilled inthe art. Also, where materials are disclosed for certain components,other materials may be used. It is therefore to be understood that theforegoing description and the appended claims are intended to cover allsuch modifications and variations as falling within the scope of thedisclosed embodiments. The following claims are intended to cover allsuch modification and variations.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more embodiments has been presented for purposes ofillustration and description. It is not intended to be exhaustive orlimiting to the precise form disclosed. Modifications or variations arepossible in light of the above teachings. The one or more embodimentswere chosen and described in order to illustrate principles andpractical application to thereby enable one of ordinary skill in the artto utilize the various embodiments and with various modifications as aresuited to the particular use contemplated. It is intended that theclaims submitted herewith define the overall scope.

1. An apparatus, comprising: at least one electrode configured to detectan electrical signal associated with a user of a target authenticationdevice, the electrical signal representing an authentication code forthe target authentication device; and an authentication receiver modulecoupled to the at least one electrode, the authentication receivermodule configured to receive the electrical signal from the at least oneelectrode and to determine whether the electrical signal matches apredetermined criterion to authenticate the identity of the user basedon the electrical signal.
 2. The apparatus of claim 1, furthercomprising a transbody conductive communication module to receive atransbody conductive signal representing the authentication code for thetarget authentication device.
 3. The apparatus of claim 1, furthercomprising a physiological sensing module to receive at least onephysiological signal representing the authentication code for the targetauthentication device.
 4. The apparatus of claim 3, wherein a biometricsignature is derived from the at least one physiological signal and thebiometric signature is compared to a user-associated signature is,wherein the user-associated signature is derived from biometric datastored in a memory over time to generate a baseline biometric signature,wherein the authentication module device compares the biometricsignature to the baseline biometric signature to authenticate theidentity of the user
 5. The apparatus of claim 4, wherein theuser-associated signature is derived from a source external to theapparatus.
 6. The apparatus of claim 1, further comprising a decoder todecode the detected electrical signal.
 7. The apparatus of claim 6,further comprising a compare module to compare the decoded detectedelectrical signal with established criteria.
 8. The apparatus of claim1, further comprising a module to encode the detected electrical signalwith a secret and to retransmit the encoded signal back to the receivermodule where it is compared to an expected result dependent onmathematical properties of the encoding and the secret.
 9. A module,comprising: at least one electrode configured to couple an electricalsignal associated with a user to a target authentication device, theelectrical signal representing an authentication code for the targetauthentication device; and an authentication transmission module coupledto the at least one electrode, the authentication transmission moduleconfigured to transmit the electrical signal from the at least oneelectrode.
 10. The module of claim 9, further comprising an encoder toencode the detected electrical signal.
 11. The module of claim 9,further comprising a transbody conductive communication module totransmit a transbody conductive signal representing the authenticationcode for the target authentication device.
 12. The module of claim 11,wherein the transbody conductive communication module comprises an eventmarker system.
 13. The module of claim 12, wherein the event markersystem is ingestible.
 14. The module of claim 11, wherein the transbodyconductive communication module is configured as an enclosingarrangement for a mobile device.
 15. The module of claim 9, furthercomprising a body-associated device to transmit at least onephysiological signal representing the authentication code for the targetauthentication device.
 16. The module of claim 15, wherein thebody-associated device is removably attachable to a skin surface of theuser.
 17. The module of claim 15, wherein the body-associated device isimplantable below the skin of the user.
 18. The module of claim 15,wherein the body-associated device is configured to authenticate achallenge-response authentication.
 19. The module of claim 15, whereinthe body-associated device is configured to be destroyed when removedfrom the body.
 20. A method comprising: detecting by at least oneelectrode an electrical signal associated with a user of the targetauthentication device, the electrical signal representing anauthentication code for the target authentication device; receiving byan authentication receiver module coupled to the at least one electrode,the electrical signal from the at least one electrode; and determiningby a processor whether the electrical signal matches a predeterminedcriterion to authenticate the identity of the user based on theelectrical signal. 21-25. (canceled)